SCI 70 HAND SANITIZER GEL- alcohol gel

SCI 70 Hand Sanitizer Gel by

Drug Labeling and Warnings

SCI 70 Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Southern Chem Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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.
5. Carbomer
6. Fragrance

.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For Hand-washing to decrease bacteria on skin - recommended for repeat use.

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 immediately

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

• Wet hands thoroughly with product, and allow to dry without wiping. For Children under six, use only under adult supervision.

Other information

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

Inactive ingredients

Purified water, hydrogen peroxide, Carbomer, fragrance and Glycerin

Package Label - Principal Display Panel

46 mL NDC: 55549-002-32

or

1892 mL NDC: 55549-002-64

or

3785 mL NDC: 55549-002-01

or

118927 mL NDC: 55549-002-05

or

118927 mL NDC: 55549-002-55

or

946353 mL NDC: 55549-002-25

or

1135500 mL NDC: 55549-002-30

INGREDIENTS AND APPEARANCE

SCI 70 HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55549-002
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)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	1 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	4 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55549-002-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 55549-002-64	1892 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 55549-002-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 55549-002-05	18927 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020
5	NDC: 55549-002-55	208198 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
6	NDC: 55549-002-25	946353 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
7	NDC: 55549-002-30	1135500 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
8	NDC: 55549-002-02	74 mL in 1 PACKET; 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

Labeler - Southern Chem Industries LLC (056025778)

Registrant - Southern Chem Industries LLC (056025778)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Chem Industries LLC		056025778	manufacture(55549-002)