Proactiv Advanced Dark Spot Correcting Serum

Drug Labeling and Warnings

Drug Details [pdf]

PA PLUS ADVANCED DARK SPOT CORRECTING SERUM- hydroquinone liquid 
THE PROACTIV COMPANY 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 Advanced Dark Spot Correcting Serum

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin lightener

Use

works deep in the skin's surface to fade spots.

Warnings

For external use only

When using this product

• avoid unnecessary sun exposure and use a sunscreen.
• some users of this product may experience a mild skin irritation.
• do not use on children under 12 years of age, unless directed by a doctor.

Stop use and ask a doctor if

skin irritation becomes severe or gradual darkening of the skin occurs.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

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

Directions

• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
• after thoroughly cleansing the skin, apply a thin layer to the affected area or as directed by a doctor.
• discontinue use if no improvement is seen after 3 months of treatment.
• keep away from eyes, lips and mouth.
• avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
• lightening effect of this product may not be noticeable when used on very dark skin.
• this product may darken over time which is normal and does not affect the product performance.
• if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

water, alcohol denat., PEG-40 hydrogenated castor oil, polysorbate 20, hippophae rhamnoides oil, hydroxyethylcellulose, sodium metabisulfite, sodium sulfite, disodium EDTA, citric acid, 1,2-hexanediol, caprylyl glycol, fragrance

Questions or comments?

Within US 1-800-950-4695

Distributed by The Proactiv Company
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com ● Manufactured in Canada
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

proactiv®                    

ADVANCED
DARK SPOT 
CORRECTING SERUM                

1 FL. OZ. 30 mL

hydroquinone skin lightener

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Box

proactiv®  

ADVANCED
DARK SPOT 
CORRECTING SERUM  

0.33 FL.OZ. 10 mL

hydroquinone skin lightener

PA PLUS ADVANCED DARK SPOT CORRECTING SERUM 
hydroquinone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM SULFITE (UNII: VTK01UQK3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-050-78	1 in 1 BOX	06/11/2015	05/27/2019
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 11410-050-79	1 in 1 BOX	06/11/2015	05/27/2019
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	06/11/2015	05/27/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-050)

Revised: 12/2017

Document Id: 8bca5366-c62e-481a-9cb0-f94816ed8dab

34390-5

Set id: 105763e3-9de5-4bf6-9bd4-bfcdc84055b5

Version: 3

Effective Time: 20171204