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.

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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

PRINCIPAL DISPLAY PANEL - 7.5 mL Vial Carton
PROACTIV   CONCEALER PLUS
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-101-041 in 1 BOX12/01/199801/01/2019
17.5 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/199801/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: a75d8386-0825-4fe8-87bb-8a0f6bbce7dc
Set id: 6c0e1bd5-59ee-4770-a7c0-47435697d400
Version: 2
Effective Time: 20200108
 
THE PROACTIV COMPANY LLC