PROACTIV REPAIRING CONCEALER- salicylic acid cream

Proactiv Repairing Concealer by

Drug Labeling and Warnings

Proactiv Repairing Concealer by is a Otc medication manufactured, distributed, or labeled by The Proactiv Company, LLC, HCT PACKAGING INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PROACTIV REPAIRING CONCEALER 
salicylic acid cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-064-99	1 in 1 BOX	06/14/2017
1		4 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/14/2017

Labeler - The Proactiv Company, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
HCT PACKAGING INC.		049121643	manufacture(11410-064)