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Name:Vanilla Cream And Apple Blossom Antibacterial Hand Sanitizer
Manufacturer:Heb
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER   - 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 Type HUMAN OTC DRUG Item Code (Source) NDC:37808-265
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
GLYCERIN  
ISOPROPYL MYRISTATE  
AMINOMETHYLPROPANOL  
CARBOMER 934  
.ALPHA.-TOCOPHEROL ACETATE, D-  
VANILLA  
APPLE  
ALOE VERA LEAF  
MANNITOL  
POWDERED CELLULOSE  
HYPROMELLOSES  
FERRIC OXIDE RED  
D&C RED NO. 33  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-265-02 59 mL in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/03/2011

Labeler - HEB (007924756)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 01/2011 HEB



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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