Active Ingredient(s)

Alcohol 62% 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 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 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.

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

purified water USP, glycerin, PEG-10 dimethicone, fragrance

Package Label - Principal Display Panel

1 gallon NDC: 75009-662-01

3780ml label

5 gallon NDC: 75009-662-02

18920ml label

55 gallon NDC: 75009-662-03

208190ml label

275 gallon NDC: 75009-662-04

1040980ml label

APPLE FOAMING HAND SANITIZER
apple foaming hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75009-662
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)	0.01 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
DIMETHICONE 200 (UNII: RGS4T2AS00)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75009-662-01	3780 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020
2	NDC:75009-662-02	18920 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020
3	NDC:75009-662-03	208190 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
4	NDC:75009-662-04	1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020

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

Labeler - Alpha Aromatics (041723545)

Name	Address	ID/FEI	Business Operations
Establishment
Alpha Aromatics		041723545	manufacture(75009-662)

APPLE FOAMING HAND SANITIZER 62%(V/V)