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

CLARIFYING TONER  2%
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82746-321
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82746-321-14	115 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/12/2023

Labeler - Clove Hill LLC (071183319)

Revised: 1/2023

Document Id: f3320371-a6cf-9129-e053-2a95a90ad07b

34390-5

Set id: f218bb9f-8683-6ccb-e053-2a95a90a13d2

Version: 4

Effective Time: 20230126