ANTIBACTERIAL HAND  - benzalkonium chloride gel 
MAYBORN USA, INC.

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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease

Recommended for repeated use.

Warnings

For external use only.

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of gel into the palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together until dry.

Inactive ingredients

Water, cetrimonium chloride, glycereth-2 cocoate, behentrimonium chloride, acrylates/diethylaminoethyl methacrylate copolymer, lactic acid, tetrasodium EDTA.

tommee tippee

closer to nature

ANTIBACTERIAL HAND GEL

CLEANS IN SECONDS

KILLS 99.9% of BACTERIA

FREE from ALCOHOL

CHLORINE, FRAGRANCE and DYES

5.07fl oz

(150ml)

container label


ANTIBACTERIAL HAND  
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76273-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
LACTIC ACID (UNII: 33X04XA5AT)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76273-001-0150 mL in 1 BOTTLE, PLASTIC
2NDC:76273-001-02150 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/27/2011
Labeler - MAYBORN USA, INC. (031274363)
Establishment
NameAddressID/FEIBusiness Operations
ORGANICA (UK) LTD235330151manufacture

Revised: 7/2011
Document Id: b36e8ab8-cb05-4d04-951e-7722b38a00bd
Set id: db14361c-04d8-457d-ab97-72c268ae116f
Version: 1
Effective Time: 20110727
 
MAYBORN USA, INC.