Label: ISOMERS CLEAR SKIN ACNE TREATMENT GEL- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 64990-601-01 - Packager: Isomers Laboratories Inc
- 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 21, 2010
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- ACTIVE INGREDIENT
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
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WARNINGS
- For External Use Only
- Keep away from eyes
- Using other topical medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin, if this occurs only one medication should be used
- In case of accidental ingestion seek professional advice or contact a poison control center immediately
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INACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Purified Water, Propylene Glycol, Optunia Ficus indica Stem Extract, Boerhavia Diffusa Root Extract, Thermus Thermophilus Ferment, Glycerin, Pentylene Glycol, Zinc PCA, Hydroxyethyl Cellulose, Phenoxyethanol, Decylene Glycol, Sodium Stearoyl Lactate, Sodium Hydroxide
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ISOMERS CLEAR SKIN ACNE TREATMENT GEL
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64990-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 0.02 mL in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) Phenoxyethanol (UNII: HIE492ZZ3T) Sodium Hydroxide (UNII: 55X04QC32I) OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64990-601-01 60 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/26/2009 Labeler - Isomers Laboratories Inc (253306799) Registrant - Isomers Laboratories Inc (253306799) Establishment Name Address ID/FEI Business Operations Isomers Laboratories Inc 253306799 manufacture