DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE- 70% ethanol hand sanitizer gel KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS- 70% ethanol hand sanitizer gel COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS- 70% ethanol hand sanitizer gel COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER GEL- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER- 70% ethanol hand sanitizer liquid DR LUCID HAND SANITIZER- 65% ethanol gel DR LUCID 70% IPA SANITIZER- 70% isopropanol liquid DR LUCID 91% IPA SANITIZER- 91% isopropanol liquid SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS- 70% ethanol hand sanitizer gel

Dr Lucid 70% Ethanol Hand Sanitizer Liquid With Eucalyptus by

Drug Labeling and Warnings

Dr Lucid 70% Ethanol Hand Sanitizer Liquid With Eucalyptus by is a Otc medication manufactured, distributed, or labeled by Otto Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ROSE OIL (UNII: WUB68Y35M7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-017-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC: 78346-017-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC: 78346-017-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
4	NDC: 78346-017-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC: 78346-017-05	6033 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC: 78346-017-06	400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
7	NDC: 78346-017-07	1600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC: 78346-017-08	600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
9	NDC: 78346-017-09	2400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC: 78346-017-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
11	NDC: 78346-017-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
12	NDC: 78346-017-12	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/14/2021

KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-019-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC: 78346-019-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC: 78346-019-03	15142 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
4	NDC: 78346-019-04	8000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC: 78346-019-05	22712 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC: 78346-019-06	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
7	NDC: 78346-019-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC: 78346-019-08	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
9	NDC: 78346-019-09	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
10	NDC: 78346-019-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/14/2021

COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-008-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
2	NDC: 78346-008-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/09/2020

COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-009-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
2	NDC: 78346-009-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/09/2020

DR LUCID 70% ETHANOL HAND SANITIZER GEL 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-006-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
2	NDC: 78346-006-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
3	NDC: 78346-006-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
4	NDC: 78346-006-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
5	NDC: 78346-006-06	6000 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
6	NDC: 78346-006-04	5915 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
7	NDC: 78346-006-08	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
8	NDC: 78346-006-07	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020
9	NDC: 78346-006-09	600 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
10	NDC: 78346-006-10	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
11	NDC: 78346-006-11	1774 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
12	NDC: 78346-006-12	7098 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
13	NDC: 78346-006-13	1774 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
14	NDC: 78346-006-14	7098 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
15	NDC: 78346-006-15	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
16	NDC: 78346-006-16	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
17	NDC: 78346-006-17	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
18	NDC: 78346-006-18	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
19	NDC: 78346-006-19	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
20	NDC: 78346-006-20	250000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
21	NDC: 78346-006-21	208000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
22	NDC: 78346-006-22	1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	11/17/2020
23	NDC: 78346-006-23	400 mL in 1 CASE; Type 0: Not a Combination Product	11/17/2020
24	NDC: 78346-006-24	1600 mL in 1 CASE; Type 0: Not a Combination Product	11/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

DR LUCID 70% ETHANOL HAND SANITIZER 
70% ethanol hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-007-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
2	NDC: 78346-007-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
3	NDC: 78346-007-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
4	NDC: 78346-007-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
5	NDC: 78346-007-06	6000 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
6	NDC: 78346-007-04	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
7	NDC: 78346-007-07	1774 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
8	NDC: 78346-007-08	7098 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
9	NDC: 78346-007-09	600 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
10	NDC: 78346-007-10	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
11	NDC: 78346-007-11	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
12	NDC: 78346-007-12	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
13	NDC: 78346-007-13	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
14	NDC: 78346-007-14	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
15	NDC: 78346-007-15	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
16	NDC: 78346-007-16	1500 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
17	NDC: 78346-007-17	400 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

DR LUCID HAND SANITIZER 
65% ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)	1.3 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-001-34	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78346-001-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78346-001-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78346-001-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 78346-001-11	5920 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 78346-001-35	6033 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 78346-001-69	5920 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 78346-001-77	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

DR LUCID 70% IPA SANITIZER 
70% isopropanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-003-01	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
2	NDC: 78346-003-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
3	NDC: 78346-003-10	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
4	NDC: 78346-003-24	12000 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
5	NDC: 78346-003-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
6	NDC: 78346-003-03	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/09/2020

DR LUCID 91% IPA SANITIZER 
91% isopropanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	91 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-004-00	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
2	NDC: 78346-004-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
3	NDC: 78346-004-20	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
4	NDC: 78346-004-10	12000 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
5	NDC: 78346-004-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
6	NDC: 78346-004-03	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/09/2020

SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-010-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
2	NDC: 78346-010-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020
3	NDC: 78346-010-05	208000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
4	NDC: 78346-010-06	250000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
5	NDC: 78346-010-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
6	NDC: 78346-010-04	5678 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/09/2020

DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-013-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC: 78346-013-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC: 78346-013-03	296 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
4	NDC: 78346-013-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC: 78346-013-05	6033 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC: 78346-013-06	2400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
7	NDC: 78346-013-07	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC: 78346-013-08	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
9	NDC: 78346-013-09	1600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC: 78346-013-10	5920 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
11	NDC: 78346-013-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
12	NDC: 78346-013-12	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/14/2021

DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ROSE OIL (UNII: WUB68Y35M7)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-018-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC: 78346-018-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC: 78346-018-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
4	NDC: 78346-018-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC: 78346-018-05	6033 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC: 78346-018-06	400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
7	NDC: 78346-018-07	1600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC: 78346-018-08	600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
9	NDC: 78346-018-09	2400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC: 78346-018-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
11	NDC: 78346-018-11	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/14/2021

DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS 
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78346-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78346-014-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC: 78346-014-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC: 78346-014-03	296 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
4	NDC: 78346-014-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC: 78346-014-05	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC: 78346-014-06	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
7	NDC: 78346-014-07	1600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
8	NDC: 78346-014-08	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
9	NDC: 78346-014-09	2400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC: 78346-014-10	1000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
11	NDC: 78346-014-11	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
12	NDC: 78346-014-12	15140 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/14/2021

Labeler - Otto Solutions LLC (117519859)

Establishment
Name	Address	ID/FEI	Business Operations
Otto Solutions LLC		117519859	manufacture(78346-001, 78346-003, 78346-004, 78346-006, 78346-007, 78346-008, 78346-009, 78346-010, 78346-019, 78346-013, 78346-014, 78346-018, 78346-017)