Label: TAKE CONTROL CALMING CLEANSER- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49520-104-11, 49520-104-15, 49520-104-31, 49520-104-33, view more49520-104-35, 49520-104-51 - Packager: mybody
- Category: HUMAN OTC DRUG LABEL
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 December 30, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
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ASK DOCTOR/PHARMACIST
ASK A DOCTOR OR PHARMACIST BEFORE USE IF *PREGNANT OR LACTATING. YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER, DISODIUM LAURETH SULFOSUCCINATE, SODIUM COCOYL ISETHIONATE, SODIUM LAUROAMPHOACETATE, GLYCERIN, SODIUM METHYL COCOYL TAURATE, METHYLISOTHIAZOLINONE, COCAMIDOPROPYL BETAINE, BISABOLOL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, OAT (AVENA SATIVA) KERNEL EXTRACT, DISODIUM EDTA, BETA GLUCAN, EUCALYPTUS GLOBULUS OIL, XANTHAN GUM, MENTHOL, MYRISTOYL TETRAPEPTIDE-13, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TAKE CONTROL CALMING CLEANSER
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49520-104 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) GLYCERIN (UNII: PDC6A3C0OX) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) GINGER (UNII: C5529G5JPQ) OAT (UNII: Z6J799EAJK) EDETATE DISODIUM (UNII: 7FLD91C86K) CURDLAN (UNII: 6930DL209R) EUCALYPTUS OIL (UNII: 2R04ONI662) XANTHAN GUM (UNII: TTV12P4NEE) MENTHOL (UNII: L7T10EIP3A) MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X) ACETYL CARBOXYMETHYL COCOYL GLYCINE (UNII: 3TNX4P92J3) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49520-104-31 5 mL in 1 TUBE 2 NDC:49520-104-15 150 mL in 1 BOTTLE 3 NDC:49520-104-51 1 in 1 BOX 3 NDC:49520-104-11 150 mL in 1 BOTTLE 4 NDC:49520-104-33 10 mL in 1 TUBE 5 NDC:49520-104-35 150 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/27/2012 Labeler - mybody (004460532) Establishment Name Address ID/FEI Business Operations OWEN BIOSCIENCES INC 790003045 manufacture(49520-104) Establishment Name Address ID/FEI Business Operations COSMETIC ENTERPRISES LTD 017701475 repack(49520-104)