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

Proactiv Dark Spot Correcting Serum 30 mL Carton

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Box

proactiv®  

ADVANCED
DARK SPOT 
CORRECTING SERUM
  

0.33 FL.OZ. 10 mL

hydroquinone skin lightener

Proactiv Advanced Dark Spot Correcting Serum 10 mL Carton
PA PLUS ADVANCED DARK SPOT CORRECTING SERUM 
hydroquinone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-050-781 in 1 BOX06/11/201505/27/2019
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 11410-050-791 in 1 BOX06/11/201505/27/2019
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A06/11/201505/27/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
KIK Holdco Company Inc243547333manufacture(11410-050)

Revised: 12/2017