Label: ACNE SPOT CORRECTOR MAXIMUM STRENGTH- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58876-106-31, 58876-106-91 - Packager: DR LIN SKINCARE
- 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 July 11, 2014
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
- WARNINGS
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WHEN USING
WHEN USING THIS PRODUCT
- AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
- AVOID CONTACT WTH EYES, LIPS AND MOUTH.
- AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
- SKIN IRRITATION MAY OCCUR CHARACTERIZED BY REDNESS, BURNING, TCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUEBTLY OR IN A LOWER CONCENTRATION.
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- OTHER SAFETY INFORMATION
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DIRECTIONS
- CLEANSE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
- APPLY A THIN LAYER DIRECTLY TO AFFECTED AREA 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 CCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
- IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT.
- STORE AT 60°F - 90°F.
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE SPOT CORRECTOR MAXIMUM STRENGTH
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58876-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) ARBUTIN (UNII: C5INA23HXF) KOJIC ACID (UNII: 6K23F1TT52) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CALENDULOSIDE E (UNII: 184358RYCU) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58876-106-91 1 in 1 BOX 1 NDC:58876-106-31 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/13/2013 Labeler - DR LIN SKINCARE (622329980) Establishment Name Address ID/FEI Business Operations Westwood Laboratories Inc. 069926483 manufacture(58876-106) , pack(58876-106)
