ANTISEPTIC GEL- 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

OTHER INFORMATION

INACTIVE INGREDIENTS

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

label

ANTISEPTIC GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76598-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76598-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
2NDC:76598-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
3NDC:76598-001-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
4NDC:76598-001-045000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
5NDC:76598-001-0520000 mL in 1 PACKAGE; Type 0: Not a Combination Product04/24/2020
6NDC:76598-001-06200000 mL in 1 DRUM; Type 0: Not a Combination Product04/24/2020
7NDC:76598-001-071000000 mL in 1 TANK; Type 0: Not a Combination Product04/24/2020
8NDC:76598-001-084500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
9NDC:76598-001-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - Bioagaves de la Costa, S.A. de C.V. (814644548)
Establishment
NameAddressID/FEIBusiness Operations
Bioagaves de la Costa, S.A. de C.V.814644548manufacture(76598-001)

Revised: 5/2020
Document Id: a58fd8fd-27be-f4b0-e053-2995a90af472
Set id: a40f1bf3-83a2-a029-e053-2a95a90a6afa
Version: 3
Effective Time: 20200513
 
Bioagaves de la Costa, S.A. de C.V.