Label: START SO FRESH- salicylic acid gel
- NDC Code(s): 70626-105-13
- Packager: ASPIRE BRANDS 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 October 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
-
WARNINGS
- FOR EXTERNAL USE ONLY
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
-
DIRECTIONS
- CLEAN THE SKIN THOROUGHLY TWICE A DAY.
- WET FACE. APPLY TO HANDS, ADD WATER AND WORK PRODUCT INTO A LATHER. MASSAGE FACE GENTLY. RINSE WELL.
- BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONCE A DAY, THEN GRADUALLY INCREASE TO TWO TIMES DAILYIF NEEDED OR AS DIRECTED BY A DOCTOR.
- 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.
-
INACTIVE INGREDIENTS
WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL HYDROXYSULTANE, GLYCERIN, POLYACRYLATE-1 CROSSPOLYMER, CITRIC ACID, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, TOCPHEROL ACETATE, PROPYLENE GLYCOL, BISABOLOL, PANTHENOL, CITRIC ACID, SODIUM BENZOATE, FRAGRANCE, POTASSIUM SORBATE, DISODIUM EDTA, SORBITOL
- QUESTIONS/COMMENTS:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
START SO FRESH
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70626-105 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 WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CUCUMBER (UNII: YY7C30VXJT) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) PANTHENOL (UNII: WV9CM0O67Z) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE DISODIUM (UNII: 7FLD91C86K) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70626-105-13 100 mL in 1 TUBE; Type 0: Not a Combination Product 12/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/03/2020 Labeler - ASPIRE BRANDS INC (832462811)
