Label: TREAT SO DEEP ACNE-FIGHTING TREATMENT- salicylic acid gel
- NDC Code(s): 70626-106-15
- Packager: ASPIRE BRANDS INC
- 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 October 2, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- USE
-
WARNINGS
- FOR EXTERNAL USE ONLY
- FLAMMABLE: KEEP AWAY FROM OPEN FIRE OR FLAME.
WHEN USING THIS PRODUCT:
- AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
- SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- CLEAN THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
- COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY.
- BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONCE A DAY, THEN GRADUALLY INCREASE TO TWO TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR.
- IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY
- SENSITIVITY TEST: WE RECOMMEND A PATCH TEST BEFORE ADDING A NEW PRODUCT TO YOUR SKIN CARE ROUTINE. APPLY A SMALL AMOUNT OF PRODUCT TO FRESHLY CLEANSED SKIN SUCH AS THE UNDERSIDE OF YOUR WRIST, JAW/NECK LINE OR BEHIND THE EAR. LEAVE FOR 24 HOURS AND CHECK FOR ANY ADVERSE REACTION.
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INACTIVE INGREDIENTS
ALCOHOL DENAT., ALLANTOIN, BISABOLOL, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CITRIC ACID, DIMETHYL ISOSORBIDE, DISODIUM EDTA, GLYCERIN, HYDROXYETHYLCELLULOSE, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, PEG-60 ALMOND GLYCERIDES, PEG-40 HYDROGENATED CASTOR OIL, PEG-8/SMDI COPOLYMER, SACCHARIDE ISOMERATE, SODIUM CITRATE, SODIUM HYDROXIDE, TETRAHEXYLDECYL ASCORBATE, WATER.
- QUESTIONS/COMMENTS:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TREAT SO DEEP ACNE-FIGHTING TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70626-106 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 ALCOHOL (UNII: 3K9958V90M) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70626-106-15 1 in 1 BOX 12/05/2020 1 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/05/2020 Labeler - ASPIRE BRANDS INC (832462811)