Label: ASD 3-IN-1- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69541-001-01 - Packager: Almen Cosmetic Group AB
- 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 January 23, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Developed by Swedish plastic surgeons and skin care specialists
Cicamed ASD 3-in-1
salicylic acid 2% acne medication
Acne Treatment
- Helps deemphasize appearance of skin discoloration and scars
- Triple-active formula for treatment of acne
#1 choice of plastic surgeons and dermatologists in Sweden
Made in Sweden
Net Wt 0.5 oz. (15g)
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DOSAGE & ADMINISTRATION
Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- WARNINGS
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INACTIVE INGREDIENT
Inactive Ingredients
water, alcohol denat., zinc oxide, capylic/capric trigylceride, dimethicone, glycerin, jojoba (simmondsia chinensis) seed oil, niacinamide, olivoyl hydrolyzed wheat protein, glycolic acid, glyceryl laurate, octoxyglycerin, allantoin, aloe barbadensis leaf juice, panthenol, witch hazel (hamamelis virginiana) leaf extract, tocopherol, retinyl palmitate, xanthan gum, sodium phytate, cetearyl alcohol, glyceryl oleate, glyceryl stearate, squalane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 60, potassium hydroxide, sodium benzoate, potassium sorbate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASD 3-IN-1
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69541-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ZINC OXIDE (UNII: SOI2LOH54Z) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) NIACINAMIDE (UNII: 25X51I8RD4) OLIVE OIL (UNII: 6UYK2W1W1E) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) GLYCOLIC ACID (UNII: 0WT12SX38S) GLYCERYL LAURATE (UNII: Y98611C087) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) WITCH HAZEL (UNII: 101I4J0U34) TOCOPHEROL (UNII: R0ZB2556P8) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) XANTHAN GUM (UNII: TTV12P4NEE) PHYTATE SODIUM (UNII: 88496G1ERL) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL OLEATE (UNII: 4PC054V79P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SQUALANE (UNII: GW89575KF9) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69541-001-01 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/23/2015 Labeler - Almen Cosmetic Group AB (775651271) Establishment Name Address ID/FEI Business Operations Almen Cosmetic Group AB 775651271 manufacture(69541-001)