START SO FRESH- salicylic acid gel

START SO FRESH by

Drug Labeling and Warnings

START SO FRESH by is a Otc medication manufactured, distributed, or labeled by ASPIRE BRANDS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SALICYLIC ACID 2%

PURPOSE

ACNE TREATMENT

USE

ACNE TREATMENT TO HELP CLEAR UP AND PREVENT NEW ACNE BLEMISHES, BLACKHEADS, AND WHITEHEADS.

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

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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:

1-866-984-1433

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

START SO FRESH 
salicylic acid gel

Product 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)