Label: JON ARES ACNE CONTROL STEP 1- benzoyl peroxide cream
- NDC Code(s): 71748-101-11
- Packager: DADASHIE ACNE SYSTEM 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 August 15, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE:
-
DIRECTIONS:
- CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
- COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BECAUSE OF EXCESS 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 PHYSICIAN.
- IF BOTHERSOME DRYNESS, REDNESS, ITCHING OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. STOP USE AND ASK A PHYSICIAN IF IRRITATION BECOMES SEVERE.
- IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A PHYSICIAN.
- WARNINGS:
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DO NOT USE
DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE. THIS PRODUCT MAY CAUSE IRRITATION.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF 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. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN, WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS.
STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS, AND BECOMES SEVERE.
- KEEP OUT OF REACH OF CHILDREN
- OTHER INFORMATION.
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
JON ARES ACNE CONTROL STEP 1
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71748-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) BENZYL ALCOHOL (UNII: LKG8494WBH) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71748-101-11 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 09/30/2017 Labeler - DADASHIE ACNE SYSTEM INC (032214636)
