Label: NOXZEMA- salicyclic acid soap
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Contains inactivated NDC Code(s)
NDC Code(s): 12488-1300-1 - Packager: Alberto-Culver USA 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 December 17, 2009
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
- For external use only.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
When using this product
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
If this occurs only one medication should be used unless directed by a doctor.
- Directions
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle
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INGREDIENTS AND APPEARANCE
NOXZEMA
salicyclic acid soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12488-1300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 0.01 mL in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Butylene Glycol (UNII: 3XUS85K0RA) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12488-1300-1 177 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2010 Labeler - Alberto-Culver USA Inc. (021679448) Establishment Name Address ID/FEI Business Operations Alberto-Culver USA Inc. 021679448 ANALYSIS, MANUFACTURE