CLEAR AND COVER ACNE TREATMENT CONCEALER CLEAR AND COVER ACNE TREATMENT CONCEALER 13 FUDGE- salicylic acid cream
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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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CLEAR AND COVER ACNE TREATMENT CREAM CONCEALER/CLEAR AND COVER ACNE TREATMENT CREAM CONCEALER 13 fudge

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

for the treatment of acne
clears acne blemishes
helps prevent new acne blemishes

Warnings

For external use only.

When using this product

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
becaused excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three tiems 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

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Dimethicone, Trisiloxane, Kaolin, Polyisobutene, PEG/PPG-18/18 Dimethicone, Boron Nitride, Cyclodextrin, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Trimethylsiloxysilicate, Phenoxyethanol, Bisabolol, Caprylyl Glycol, Glycerin, Triethoxycaprylylsilane, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol, Tocopheryl Acetate, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate.
May Contain (+/-): Zinc Oxide (CI 77947), Iron Oxides (CI 77491/CI 77492/CI 77499).

Package Labeling:

Outer Package2 Inner Package2 fudge

CLEAR AND COVER ACNE TREATMENT CONCEALER CLEAR AND COVER ACNE TREATMENT CONCEALER 13 FUDGE
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:31720-965
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
KAOLIN (UNII: 24H4NWX5CO)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHAMOMILE (UNII: FGL3685T2X)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:31720-965-18	1 in 1 BOX	06/01/2020
1		3.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	06/01/2020

Labeler - S+ (572406531)