FOAMING HAND SANITIZER - benzalkonium chloride gel 
HY-VEE 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 PERCENT

PURPOSE

ANTIMICROBIAL

USES

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.  IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR RASH DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

PUMP DESIRED AMOUNT ONTO HANDS AND RUB UNTIL YOUR SKIN IS DRY.  CHILDREN UNDER THE AGE OF 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

INACTIVE INGREDIENTS

WATER, POLYSORBATE 20, ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE, TETRASODIUM EDTA, DMDM HYDANTOIN, SODIUM HYDROXIDE, BLUE 1 (CI 42090), YELLOW 5  (CI 19140).

QUESTION OR COMMENTS

1-800-289-8343

Front and back labels

image of label

FOAMING HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-240
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)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
AVOBENZONE (UNII: G63QQF2NOX)  
OCTISALATE (UNII: 4X49Y0596W)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-240-08236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/24/2011
Labeler - HY-VEE INC (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 10/2011
Document Id: 934185ee-8f44-493c-b196-a548a22a467e
Set id: eab31093-1e96-4c44-b336-55b984d723ae
Version: 1
Effective Time: 20111024
 
HY-VEE INC