HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SanitizeNow Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Alcohol (ethanol) (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.
Sterile distilled water or boiled cold water.
Hydrogen Peroxide
Glycerin
Isopropyl Myristate 0% to < 0.25%
Propylene Glycol
Carbomer and/or acrylates/alkyl polymers
Aloe Arborescens Leaf
Tocopheryl Acetate
Fragrance

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 70% 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
• in eyes. In case of contact, rinse eyes thoroughly with water

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

Water, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.

Package Label - Principal Display Panel

355 mL NDC: 74988-731-35

59 mL NDC: 74988-731-20
118 mL NDC: 74988-731-40
236 mL NDC: 74988-731-80
473 mL NDC: 74988-731-16
3.79 L NDC: 74988-731-37
208 L NDC: 74988-731-55
1041 L NDC: 74988-731-41
25741 L NDC: 74988-731-74

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74988-731
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74988-731-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
2	NDC: 74988-731-40	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
3	NDC: 74988-731-80	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
4	NDC: 74988-731-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
5	NDC: 74988-731-37	3790 mL in 1 JUG; Type 0: Not a Combination Product	06/15/2020
6	NDC: 74988-731-55	208000 mL in 1 DRUM; Type 0: Not a Combination Product	06/15/2020
7	NDC: 74988-731-41	1041000 mL in 1 TANK; Type 0: Not a Combination Product	06/15/2020
8	NDC: 74988-731-74	25741000 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/15/2020
9	NDC: 74988-731-35	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020

Labeler - SanitizeNow Inc. (117475870)

Establishment
Name	Address	ID/FEI	Business Operations
SanitizeNow Inc.		117475870	manufacture(74988-731)