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Fascy Moisture Bomb Hand Cre am Strawberry

Dosage form: cream
Ingredients: Dimethicone 0.8g in 80mL
Labeler: FASCY Co,.LTD.
NDC Code: 70991-030

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.

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Cetearyl Alcohol, Mineral Oil, Dipropylene Glycol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Sorbitan Stearate, Sodium Polyacrylate, Ethylhexyl Stearate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Butylene Glycol, Potassium Hydroxide, Trideceth-6, Butyrospermum Parkii (Shea) Butter, Panthenol, Fragaria Chiloensis (Strawberry) Fruit Extract, Allantoin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Disodium EDTA, Methylparaben, Propylparaben, Phenoxyethanol, CI 17200, CI 19140, CI 14700, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns. Keep out of reach of children. Do not keep it in direct sunlight, high or low temperature.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

How to use

How to use: Apply desired amount and massage into the hands.

How to use

How to use: Apply desired amount and massage into the hands.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FASCY MOISTURE BOMB HAND CRE AM STRAWBERRY 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70991-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone0.8 g  in 80 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:70991-030-021 TUBE in 1 CARTON
1NDC:70991-030-0180 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2016
Labeler - FASCY Co,.LTD. (689204222)
Registrant - FASCY Co,.LTD. (689204222)
Establishment
NameAddressID/FEIOperations
FASCY Co,.LTD.689204222repack(70991-030)
Establishment
NameAddressID/FEIOperations
WELCOS CO.,LTD.689131584manufacture(70991-030)

Revised: 09/2016
 
FASCY Co,.LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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