Proactiv Solution Advanced Blemish Treatment

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 ADVANCED BLEMISH TREATMENT- benzoyl peroxide cream 
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 Advanced Blemish Treatment

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 6 %

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • keep away from lips and mouth.
  • avoid unnecessary sun exposure and use a sunscreen.
  • this product may bleach hair or dyed fabrics.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation becomes severe.

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

  • Cleanse the skin thoroughly before applying medication.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, use a sunscreen.

Inactive Ingredients

water (aqua), ethoxydiglycol, cyclopentasiloxane, methylpropanediol, steareth-2, cyclohexasiloxane, steareth-21, polyquaternium-37, propylene glycol, propylene glycol dicaprylate / dicaprate, PPG-1 trideceth-6, panthenol, allantoin, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 9.45 g Carton

Rodan & Fields

proactiv®
SOLUTION

ADVANCED
BLEMISH
TREATMENT

non-comedogenic

benzoyl peroxide
acne treatment

.33 OZ. 9.45 g

PRINCIPAL DISPLAY PANEL - 9.45 g Carton

PRINCIPAL DISPLAY PANEL - 9.5 g Carton

Rodan & Fields

proactiv®
SOLUTION

ADVANCED BLEMISH TREATMENT

Traitement contre l'acné

benzoyl peroxide cream 5.0%

DIN: 02271419

0.33 OZ. / 9.5 g

Principal Display Panel - 9.5 g Carton
PROACTIV  ADVANCED BLEMISH TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-905
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
diethylene glycol monoethyl ether (UNII: A1A1I8X02B)  
cyclomethicone (UNII: NMQ347994Z)  
methylpropanediol (UNII: N8F53B3R4R)  
steareth-2 (UNII: V56DFE46J5)  
propylene glycol dicaprylate (UNII: 581437HWX2)  
propylene glycol (UNII: 6DC9Q167V3)  
panthenol (UNII: WV9CM0O67Z)  
allantoin (UNII: 344S277G0Z)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-905-091 in 1 CARTON12/01/199901/01/2019
19.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/01/199901/01/2019
PROACTIV  ADVANCED BLEMISH TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
diethylene glycol monoethyl ether (UNII: A1A1I8X02B)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
methylpropanediol (UNII: N8F53B3R4R)  
steareth-2 (UNII: V56DFE46J5)  
cyclomethicone 6 (UNII: XHK3U310BA)  
propylene glycol (UNII: 6DC9Q167V3)  
propylene glycol dicaprylate (UNII: 581437HWX2)  
panthenol (UNII: WV9CM0O67Z)  
allantoin (UNII: 344S277G0Z)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-401-091 in 1 CARTON12/01/199901/01/2019
19.45 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/199901/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: 02c1e3f5-fd10-433b-a9f1-9d6e9e6113fd
Set id: 06ef037e-0713-420f-b421-ef8e4146b8fd
Version: 2
Effective Time: 20200109
 
THE PROACTIV COMPANY LLC