VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER  - ethyl alcohol gel 
HEB

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

ETHYL ALCOHOL 62 PERCENT

PURPOSE

ANTISEPTIC

USES

TO HELP REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS 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

APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 1100F (430C).

QUESTIONS OR COMMENTS

1-866-695-3030

INACTIVE INGREDIENTS

WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE, VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200).

PACKAGE FRONT AND BACK LABELS

IMAGE OF VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER 2 FL OZ

VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER  
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 934 (UNII: Z135WT9208)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
VANILLA (UNII: Q74T35078H)  
APPLE (UNII: B423VGH5S9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-265-0259 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/03/2011
Labeler - HEB (007924756)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 1/2011
Document Id: 698e3c0d-b760-4ec7-9631-65c2c47fb097
Set id: b52566cb-2314-4131-9663-bc20950cabec
Version: 1
Effective Time: 20110103
 
HEB