Label: SCAR- dimethicone 2.0% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-1118-01 - Packager: Walgreens
- 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 April 13, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
When using this product • keep out of eyes
Stop use and ask doctor if • condition worsens • symptoms last more than 7
days or clear up and occur again within a few days
Do not use on • deep or puncture wounds • animal bites • serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients Water, Glycerin, Acetyl Hexapeptide-8,
Stearic Acid, Cetearyl Alcohol, Glycine Soja (Soybean) Oil, Allium Cepa (Onion)
Bulb Extract, Hydrolyzed Adansonia Digitata Seed Extract, Sorbitan Isostearate,
Sorbitol, C12-15 Alkyl Benzoate, Glyceryl Caprylate, Lactococcus Ferment
Lysate, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Oleifera Leaf
Extract, Camellia Sinensis Leaf Extract, Polyglyceryl-3 Distearate, Aloe
Barbadensis Leaf Extract, Magnolia Grandiflora Bark Extract, Palmitoyl
Tripeptide-1, Palmitoyl Tetrapeptide-7, Allantoin, Tocopherol, Butylene Glycol,
Carbomer, Propylene Glycol, Panthenol, Ethylhexylglycerin, Dicaprylyl Ether,
Disodium EDTA, Lauryl Alcohol, Polysorbate 20, Triethanolamine,
Phenoxyethanol. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SCAR
dimethicone 2.0% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Allantoin (UNII: 344S277G0Z) ONION (UNII: 492225Q21H) ALOE VERA LEAF (UNII: ZY81Z83H0X) Butylene Glycol (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHAMOMILE (UNII: FGL3685T2X) Dicaprylyl Ether (UNII: 77JZM5516Z) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) Glyceryl Caprylate (UNII: TM2TZD4G4A) SOYBEAN OIL (UNII: 241ATL177A) Lauryl Alcohol (UNII: 178A96NLP2) MAGNOLIA GRANDIFLORA BARK (UNII: J4XF5T6418) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) Palmitoyl Tripeptide-1 (UNII: RV743D216M) Panthenol (UNII: WV9CM0O67Z) Phenoxyethanol (UNII: HIE492ZZ3T) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sorbitol (UNII: 506T60A25R) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1118-01 28.3 g in 1 PACKAGE; Type 0: Not a Combination Product 02/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/29/2016 Labeler - Walgreens (008965063) Registrant - Product Quiest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quiest Mfg 927768135 manufacture(0363-1118) , label(0363-1118)
