HAND SANITIZER- isopropyl 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:

Isopropyl Alcohol (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)

Isopropyl 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

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

59 mL NDC: 74988-733-20
118 mL NDC: 74988-733-40
177 mL NDC: 74988-733-77
236 mL NDC: 74988-733-80
355 mL NDC: 74988-733-35

473 mL NDC: 74988-733-16

946 ml NDC: 74988-733-11

3.79 L NDC: 74988-733-37

1041 L NDC: 74988-733-41

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74988-733
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74988-733-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
2	NDC: 74988-733-37	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
3	NDC: 74988-733-11	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
4	NDC: 74988-733-41	1041000 mL in 1 TANK; Type 0: Not a Combination Product	07/16/2020
5	NDC: 74988-733-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
6	NDC: 74988-733-40	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
7	NDC: 74988-733-77	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
8	NDC: 74988-733-80	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
9	NDC: 74988-733-35	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/16/2020

Labeler - SanitizeNow Inc. (117475870)

Establishment
Name	Address	ID/FEI	Business Operations
SanitizeNow Inc.		117475870	manufacture(74988-733)