ANVEN- alcohol gel 
Gama Cosmetics, S.A. de C.V.

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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

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

Glycerin, polyacrylic acid (Carbomer), triethanolamine (Trolamine), water.

Package Label - Principal Display Panel

240 mL NDC: 79471-001-01

Anven

Package Label- Principal Display Panel

480mL NDC: 79471-001-02

Anven

Package Label- Principal Display Panel

960 mL NDC: 79471-001-03

Anven

ANVEN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79471-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.12 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) 1.14 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.68 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.03 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79471-001-01240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/202212/31/2022
2NDC:79471-001-02480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/202212/31/2022
3NDC:79471-001-03960 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/202212/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00301/24/202212/31/2022
Labeler - Gama Cosmetics, S.A. de C.V. (588335161)
Registrant - Gama Cosmetics, S.A. de C.V. (588335161)
Establishment
NameAddressID/FEIBusiness Operations
Gama Cosmetics, S.A. de C.V.588335161manufacture(79471-001)

Revised: 4/2024
 
Gama Cosmetics, S.A. de C.V.