Clove Hill (as PLD) - Clarifying Salicylic Toner (82746-321)

CLARIFYING TONER by

Drug Labeling and Warnings

CLARIFYING TONER by is a Otc medication manufactured, distributed, or labeled by Clove Hill LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLARIFYING TONER 2%- salicylic acid solution 
Clove Hill LLC

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.

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Clove Hill (as PLD) - Clarifying Salicylic Toner (82746-321)

ACTIVE INGREDIENT

SALICYLIC ACID 2%

PURPOSE

Acne medication

USES

  • For the treatment of acne

WARNINGS

For external use only.

When using this product

  • skin irritation andndryness 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. If swalloed, get medical help or contact a Poison Control Center right away.

Flammable: Keep away from fire or flame.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • CLEAN THE SKIN THOROUGHLY BEFORE APPLYING THE 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 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 OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY
  • IF GOING OUTSIDE, APPLY SUNCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A DOCTOR.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE. KEEP AWAY FROM HEAT AND DIRECT SUNLIGHT.

INACTIVE INGREDIENTS

WATER, PROPANEDIOL, GLYCERIN, COCAMIDOPROPYL DIMETHYLAMINE, SODIUM CITRATE, BENZYL ALCOHOL, GLYCERYL CAPRYLATE, GLYCERYL UNDECYLENATE, CAMELLIA SINENSIS LEAF EXTRACT

LBL CLARIFYING SALICYLIC TONER

CLARIFYING TONER  2%
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82746-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82746-321-14115 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/12/2023
Labeler - Clove Hill LLC (071183319)

Revised: 1/2023
 

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