ANTISEPTIC GEL HAND SANITIZER 70 V/V- alcohol gel
Bioagaves de la Costa, S.A. de C.V.

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

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that can potencially 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 15º - 30ºC (59-86F).
Avoid freezing and excessive heat above 40ºC (104F)

INACTIVE INGREDIENTS

Glycerin, carbomer, triethanolamine, purified water USP, aloe vera.

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ANTISEPTIC GEL HAND SANITIZER 70 V/V
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76598-004
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
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76598-004-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
2	NDC:76598-004-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
3	NDC:76598-004-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
4	NDC:76598-004-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
5	NDC:76598-004-05	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/24/2020
6	NDC:76598-004-06	3785 mL in 1 DRUM; Type 0: Not a Combination Product	04/24/2020
7	NDC:76598-004-07	1000000 mL in 1 TANK; Type 0: Not a Combination Product	04/24/2020
8	NDC:76598-004-08	20000 mL in 1 DRUM; Type 0: Not a Combination Product	04/24/2020
9	NDC:76598-004-09	200000 mL in 1 TANK; Type 0: Not a Combination Product	04/24/2020
10	NDC:76598-004-10	4 mL in 1 POUCH; Type 0: Not a Combination Product	09/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/24/2020

Labeler - Bioagaves de la Costa, S.A. de C.V. (814644548)

Name	Address	ID/FEI	Business Operations
Establishment
Bioagaves de la Costa, S.A. de C.V.		814644548	manufacture(76598-004)