Proactiv Solution Clear Purifying Mask

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  CLEAR PURIFYING MASK- sulfur gel 
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 Clear Purifying Mask

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sulfur 6%

Purpose

Acne Treatment

Use

For the management of acne

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. If excessive skin irritation develops or increases, discontinue use and consult a doctor.

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.

Directions

  • apply to cleansed face
  • leave on for 10-15 minutes
  • rinse with warm water

For oily skin:

  • apply a thin layer to the affected area
  • allow to dry
  • do not rinse off
  • if bothersome dryness or peeling occurs, reduce application use
  • use 2 to 3 times a week

Inactive Ingredients

water (aqua), dicaprylyl carbonate, montmorillonite, alcohol denat., neopentyl glycol diheptanoate, glycerin, acacia senegal gum, triethanolamine, olive oil PEG-7 esters, butylene glycol, camellia sinensis leaf extract, cymbopogon schoenanthus extract, geranium maculatum extract, melaleuca alternifolia (tea tree) leaf oil, dipotassium glycyrrhizate, hydroxyphenyl propamidobenzoic acid, tocopheryl acetate, allantoin, pentylene glycol, ethylhexylglycerin, butyl oleate, glyceryl acrylate/acrylic acid copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethoxydiglycol, disodium EDTA, butylparaben, ethylparaben, isobutylparaben, methylparaben, phenoxyethanol, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30 mL Carton

Rodan & Fields

proactiv®
SOLUTION

Clear Purifying
Mask

non-comedogenic

sulfur acne treatment

1 FL OZ 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Carton
PROACTIV   CLEAR PURIFYING MASK
sulfur gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-812
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-812-291 in 1 BOX02/01/200801/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/01/200801/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: a10d6c24-6291-48e6-9d57-9e0c15b767bd
Set id: 629323fa-5b08-4f50-b8f2-451d51c2b2e4
Version: 2
Effective Time: 20200114
 
THE PROACTIV COMPANY LLC