Proactiv Solution Concealer Plus

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  CONCEALER PLUS- sulfur 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.

----------

Proactiv Solution Concealer Plus

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sulfur 8%

Purpose

Acne Treatment Cream

Use

For the management of acne

Directions

• dot concealer lightly on blemishes
• use fingertips or sponge to blend
• if going outside, use a sunscreen

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes.

OTC - DO NOT USE SECTION

Do not use under eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs.

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.

Inactive Ingredients

water (aqua), octyldodecanol, tricaprylin, sorbitol, stearic acid, magnesium aluminum silicate, glyceryl polymethacrylate, glycol stearate, propylene glycol, cyclopentasiloxane, cyclohexasiloxane, stearyl alcohol, ceteareth-20, xanthan gum, talc, triethanolamine, imidazolidinyl urea, methylparaben, propylparaben, fragrance (parfum), iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891)

PRINCIPAL DISPLAY PANEL - 7.5 mL Vial Carton

Rodan & Fields

proactiv®
SOLUTION

CONCEALER
PLUS

non-comedogenic

sulfur
acne treatment

.25 FL. OZ. 7.5 mL

PROACTIV   CONCEALER PLUS
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 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: 11410-101-04	1 in 1 BOX	12/01/1998	01/01/2019
1		7.5 mL in 1 VIAL, PLASTIC; 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	12/01/1998	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: a75d8386-0825-4fe8-87bb-8a0f6bbce7dc

34390-5

Set id: 6c0e1bd5-59ee-4770-a7c0-47435697d400

Version: 2

Effective Time: 20200108