PROACTIV REPAIRING CONCEALER- salicylic acid cream
Alchemee, 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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Proactiv Repairing Concealer

Drug Facts

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

When using this product

do not use this product more than three times per day.
skin irritation and dryness are 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.
avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation becomes severe.

Keep out of reach of children

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

Directions

Apply to clean skin.
Dab onto blemishes, scars, dark spots and other imperfections by using a concealer brush or fingertip.
Layer and blend well onto the area(s) needing coverage.

Inactive ingredients

caprylic/capric triglyceride, octyldodecanol, euphorbia cerifera (candelilla) wax, copernicia cerifera (carnauba) wax, jojoba esters, polyethylene, phenoxyethanol, ethylhexylglycerin, stearalkonium bentonite, dimethicone, silica, allantoin, tocopheryl acetate, ascorbyl palmitate, propylene carbonate, mica, titanium dioxide, iron oxides

Distributed by The Proactiv Company LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com
Within US 1-800-950-4695
Made in China
Proactiv is a trademark of The Proactiv Company Sàrl
PA.01276

PRINCIPAL DISPLAY PANEL - 4G

PROACTIV REPAIRING CONCEALER
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-064
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Medium-chain Triglycerides (UNII: C9H2L21V7U)
Octyldodecanol (UNII: 461N1O614Y)
Candelilla Wax (UNII: WL0328HX19)
Carnauba Wax (UNII: R12CBM0EIZ)
Hydrolyzed Jojoba Esters (potassium Salts) (UNII: CH428W5O62)
High Density Polyethylene (UNII: UG00KM4WR7)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Dimethicone (UNII: 92RU3N3Y1O)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Allantoin (UNII: 344S277G0Z)
.alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Propylene Carbonate (UNII: 8D08K3S51E)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)
Stearalkonium Chloride (UNII: 0OUO26BB88)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-064-99	1 in 1 BOX	06/14/2017	01/04/2021
1		4 g in 1 JAR; 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	06/14/2017	01/04/2021

Labeler - Alchemee, LLC (080216357)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	manufacture(11410-064)

Revised: 11/2022

Document Id: 7b1211e7-5b70-4fc6-a9f3-2410a61a8975

Set id: bda4ec11-2630-4bcd-bb8d-8c1a91c3e85c

Version: 2

Effective Time: 20221129

Alchemee, LLC