Label: AN ADC SP INTENSIVE WRINKLE- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69153-100-01, 69153-100-02 - Packager: AN Co Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 24, 2016
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- ACTIVE INGREDIENT
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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
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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
- Suggested use
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AN ADC SP INTENSIVE WRINKLE
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69153-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 0.65 g in 50 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69153-100-02 1 in 1 CARTON 05/01/2016 1 NDC:69153-100-01 50 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/01/2016 Labeler - AN Co Ltd. (688448454) Registrant - AN Co Ltd. (688448454) Establishment Name Address ID/FEI Business Operations AN Co Ltd. 688448454 manufacture(69153-100)
