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PRIME PRIMER HYDRATING

Dosage form: cream
Ingredients: Dimethicone 0.9mg in 30mL
Labeler: F&CO Co., Ltd.
NDC Code: 69106-170

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 3.0%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Cyclopentasiloxane, Glycerin, Cyclomethicone, Methyl Methacrylate Crosspolymer, Alcohol Denat., Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Xylitol, PEG/PPG-20/20 Dimethicone, Dimethicone/vinyl Dimethicone Crosspolymer, Hexyl Laurate, Magnesium Sulfate, Methylparaben, Chlorphenesin, Talc, Propylparaben, Fragrance(Parfum), Aloe Barbadensis Leaf Juice, Titanium Dioxide (CI 77891), Sodium Hyaluronate, Ultramarines (CI 77007), Phenoxyethanol, Triethoxycaprylylsilane, Montmorillonite, Butylparaben, Ethylparaben, Isobutylparaben, Butylene Glycol, Potassium Sorbate, Sodium Benzoate, Glyceryl Cprylate, Viscum Album (Mistletoe) Extract, Juniperus Communis Fruit Extract, Melissa Officinalis Extract, Arctium Majus Root Extract, Saponaria Officinalis Leaf/Root Extract, Hypericum Perforatum Extract, Salvia Officinalis (Sage) Water, Hamamelis Virginiana (Witch Hazel) Water, Mentha Piperita (Peppermint) Extract, Onsen-Sui

PURPOSE

Purpose: Skin protectant

CAUTION

CAUTION:
If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

How to Use

How to Use: Apply a pea-sized amount before BB cream or foundation.

Dosage & Administration

Dosage & Administration:
Oil-free, mineral-based primer that creates a smooth, radiant, and long-lasting canvas for a satin-soft polished look while its hydrating formula('Pure Nature Complex' & 'Green Clay') helps your makeup stay put.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRIME PRIMER HYDRATING 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69106-170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone0.9 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:69106-170-0130 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2014
Labeler - F&CO Co., Ltd. (690166186)
Registrant - F&CO Co., Ltd. (690166186)
Establishment
NameAddressID/FEIOperations
F&CO Co., Ltd.690166186manufacture(69106-170)

Revised: 08/2014
 
F&CO 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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