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Name:Vanilla Fig Hand Sanitizer
Manufacturer:Unique Holding Group Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

VANILLA FIG HAND SANITIZER  - alcohol liquid 
Unique Holding Group 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

Ethyl Alcohol 62%  


Purpose:

Sanitizer


Uses:

To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.


Warnings:

For external use only-hands.
Use only as directed.
Excessive use or prolonged exposure may cause irritation to the skin.
Discontinue use if irritation, redness, or itching occurs.
Flammable. Keep away from heat and flame

When Using This Product:

Keep out of eyes. In case of contact with eyes, flush immediately with water and call a doctor.

Avoid contact with broken skin



Stop Use And Ask A Doctor if irritation or redness develops




Keep Out of Reach of Children

In case ofaccidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Directions:

Put a thumb size amount in your palm and rub hands together briskly until dry

Other Information

Do not store in temperatures over 118F

Children under six years of age should be supervised while using this product.

May discolor certain fabrics



Inactive Ingredients

aloe barbadensis gel, carbomer, deionized water, Fragrance, glycerin, propylene glycol, D and C Red No. 33, triethanolamine, and vitamin E

labelabel


VANILLA FIG HAND SANITIZER 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:25225-018(NDC:None)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
Water 35.5998 g  in 100 g
Propylene Glycol 0.5 g  in 100 g
Glycerin 1 g  in 100 g
ALOE VERA LEAF 0.01 g  in 100 g
CARBOMER HOMOPOLYMER TYPE C 0.33 g  in 100 g
ALPHA-TOCOPHEROL 0.01 g  in 100 g
TROLAMINE 0.35 g  in 100 g
VANILLA 0.2 g  in 100 g
D&C RED NO. 33 0.0002 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25225-018-01 28 g in 1 BOTTLE, PLASTIC None
2 NDC:25225-018-02 59 g in 1 BOTTLE, PLASTIC None
3 NDC:25225-018-04 237 g in 1 BOTTLE, PLASTIC None
4 NDC:25225-018-05 500 g in 1 BOTTLE, PLASTIC None
5 NDC:25225-018-03 222 g in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 07/13/2010

Labeler - Unique Holding Group Inc (529047265)
Registrant - Unique Holding Group Inc (529047265)
Establishment
Name Address ID/FEI Operations
Unique Holding Group Inc 529047265 manufacture

Revised: 11/2010 Unique Holding Group Inc



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


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