Alcohol-Free Anitseptic Gel by Bioagaves de la Costa, S.A. de C.V.

Alcohol-Free Anitseptic Gel by

Drug Labeling and Warnings

Alcohol-Free Anitseptic Gel by is a Otc medication manufactured, distributed, or labeled by Bioagaves de la Costa, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL-FREE ANITSEPTIC GEL- benzalkonium chloride 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

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria that can potencially cause disease.

For use when soap and water are not available.

WARNINGS

Do not freeze. For external use only.

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 just one drop on hands to cover all surfaces.

OTHER INFORMATION

  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces

INACTIVE INGREDIENTS

Water, hyroxyethyl cellulose, glycerin, methylparaben, propylene glycol, DMDM H

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ALCOHOL-FREE ANITSEPTIC GEL 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76598-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76598-009-014 mL in 1 POUCH; Type 0: Not a Combination Product04/24/2020
2NDC: 76598-009-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
3NDC: 76598-009-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
4NDC: 76598-009-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
5NDC: 76598-009-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
6NDC: 76598-009-063780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
7NDC: 76598-009-074500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
8NDC: 76598-009-0820000 mL in 1 JUG; Type 0: Not a Combination Product04/24/2020
9NDC: 76598-009-09200000 mL in 1 JUG; Type 0: Not a Combination Product04/24/2020
10NDC: 76598-009-101000000 mL in 1 JUG; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/202009/03/2020
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(76598-009)

Revised: 9/2020
Document Id: ae6a3b34-f83b-70cc-e053-2a95a90a0411
Set id: adba2cd2-192f-afa6-e053-2995a90a3bcf
Version: 3
Effective Time: 20200903