Proactiv Solution Skin Lightening Lotion

Proactiv by

Drug Labeling and Warnings

Proactiv by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SKIN LIGHTENING- hydroquinone lotion 
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 Solution Skin Lightening Lotion

SPL UNCLASSIFIED SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation becomes severe or gradual darkening of the skin occurs.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• after cleansing, apply a thin layer on the affected areas, or as directed by a doctor
• discontinue use if no improvement is seen after three months of treatment

Other information

• 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

Inactive Ingredients

water (aqua), octyldodecanol, cyclopentasiloxane, hexylene glycol, glycolic acid, polyquaternium-37, propylene glycol dicaprylate/dicaprate, cyclohexasiloxane, cetearyl alcohol, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, glyceryl dilaurate, glyceryl stearate, PPG-1 trideceth-6, PEG-100 stearate, PEG-40 stearate, propylene glycol, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton

Rodan & Fields

proactiv®
SOLUTION

SKIN
LIGHTENING
LOTION

helps to
fade discolorations
perfect for all skin types

1 FL. OZ. 30 mL

PROACTIV  SKIN LIGHTENING
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-408-29	1 in 1 BOX	01/01/1998	01/01/2019
1		30 mL in 1 TUBE; 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	01/01/1998	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: 6c6fda56-9da7-4f41-8b5f-787ebf0c293a

34390-5

Set id: 863fd03d-5e44-4ea2-9ae4-1e89361aa9fb

Version: 2

Effective Time: 20200128

 

THE PROACTIV COMPANY LLC