EQUINOX- alcohol gel
ATA FOOD LTD LIABILITY CO

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.

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Active Ingredients

Alcohol 70% v/v.

Purpose

Antiseptic

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.

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 15-30oC (59-86oF).
Avoid freezing and excessive heat above 40oC (104oF).

Inactive ingredients

Deionized water, glycerin, aloe vera

Package Label - Principal Display Panel

Label

EQUINOX
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79229-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79229-002-01	100 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
2	NDC:79229-002-02	200 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
3	NDC:79229-002-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
4	NDC:79229-002-04	1000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
5	NDC:79229-002-05	5000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
6	NDC:79229-002-06	10000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
7	NDC:79229-002-07	20000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
8	NDC:79229-002-08	30000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2020

Labeler - ATA FOOD LTD LIABILITY CO (074004291)