AN ADC SP INTENSIVE WRINKLE- dimethicone cream 
AN 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 1.3%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Cyclopentasiloxane/PEG-10 Dimethicone/Vinyl Dimechicone Cross Polymer, Dipropylene Glycol, Olive Oil Glycereth-8 Esters, Panthenol, Cetyl Ethylhexanoate, Phytosqualane, 1,2-Hexanediol, Cetyl Alcohol, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Polyacrylamide/C13-14 Isoparaffin/ Laureth-7, Polysorbate 60, Ethoxydiglycol, Trimethylpentanediol/Adipic Acid Copolymer, CeramideNP/Hydrogenated Polydecene/Stearic Acid/ButyrospermumParkii(Shea) Butter/Ceteareth-20/Glyceryl Citrate/Lactate/Linoleate/Oleate Butylene glycol, Phenoxyethanol, Beta-Glucan, Dipotassium Glycyrrhizate, Fragrance, Sodium Stearoyl Glutamate, Hydrogenated Lecithin, Carbomer, Triethanolamine, Sodium Polyacrylate, Tocopheryl Acetate, Xanthan Gum, Adenosine, Disodium EDTA, Sodium Hyaluronate, Copper Tripeptide-1, Palmitoyl Pentapeptide-4, Acetyl Hexapeptide-8

PURPOSE

Purpose: Skin Protectant

WARNINGS

Precautions on use: 1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms. A) If there are red spots, swelling, itchiness, or irritation B) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight. 2. Precautions on storage and handling A) Make sure to close the cap after use. B) Keep out of the reach of children. C) Do not keep the product in a hot or cold place or a place getting direct sunlight. 3. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Suggested use

Suggested use: At the final stage of basic makeup, apply an appropriate amount of the cream to the whole face and gently massage the face upwards to help the skin absorb the nutrients.

DOSAGE & ADMINISTRATION

Dosage & administration: Apply 3~4g of cream to the whole face evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AN ADC SP INTENSIVE WRINKLE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69153-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.65 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69153-100-021 in 1 CARTON05/01/2016
1NDC:69153-100-0150 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2016
Labeler - AN Co Ltd. (688448454)
Registrant - AN Co Ltd. (688448454)
Establishment
NameAddressID/FEIBusiness Operations
AN Co Ltd.688448454manufacture(69153-100)

Revised: 6/2016
Document Id: 608b9fe3-2c34-4da4-868b-00badce3656c
Set id: 43d013b4-edc5-44be-a35a-c5d0d82e70b9
Version: 1
Effective Time: 20160624
 
AN Co Ltd.