PRIME PRIMER CLASSIC by F&CO Co., Ltd.

PRIME PRIMER CLASSIC by

Drug Labeling and Warnings

PRIME PRIMER CLASSIC by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRIME PRIMER CLASSIC- dimethicone cream 
F&CO Co., Ltd.

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 1.5%

INACTIVE INGREDIENT

Inactive ingredients:
Cyclopentasiloxane, Dimethicone Crosspolymer, Water, Cyclohexasiloxane, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Titanium Dioxide, Sodium Chloride, Isododecane, Disteardimonium Hectorite, Propylene Carbonate, Fragrance

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:
Clean, satin-finish formula that minimizes the appearance of shine, pores, and fine lines, and creates a smooth, uniform canvas for flawless makeup application. Recommended for those with large pores and uneven skin surface.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

PRIME PRIMER CLASSIC 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69106-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69106-160-0130 mL in 1 CARTON; Type 0: Not a Combination Product07/01/201411/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/201411/01/2019
Labeler - F&CO Co., Ltd. (690166186)
Registrant - F&CO Co., Ltd. (690166186)
Establishment
NameAddressID/FEIBusiness Operations
F&CO Co., Ltd.690166186manufacture(69106-160)

Revised: 1/2020
 
F&CO Co., Ltd.