Proactiv Solution Soothing Scalp Treatment Antidandruff Shampoo

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  SOOTHING SCALP TREATMENT ANTIDANDRUFF- pyrithione zinc shampoo 
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 Soothing Scalp Treatment
Antidandruff Shampoo

Drug Facts

Active Ingredient

Zinc Pyrithione 1%

Purpose

Antidandruff

Use

for the relief of itching and flaking associated with dandruff

Warnings

For external use only

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

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

Directions

• Shake well before using.
• Wet hair.
• Massage into scalp.
• Lather thoroughly.
• Leave on 1-2 minutes.
• Rinse well.
• Repeat if necessary.
• For best results, use at least twice a week or as directed by a doctor.

Inactive Ingredients

water (aqua), ammonium lauryl sulfate, distearyl phthalic acid amide, cocamide MIPA, dimethicone, nasturtium officinale extract, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, echinacea angustifolia extract, rosmarinus officinalis (rosemary) leaf extract, butylene glycol, PEG/PPG-18/18 dimethicone, acrylates/C10-30 alkyl acrylate crosspolymer, ammonium chloride, aminomethyl propanol, citric acid, disodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, methylparaben, fragrance (parfum), blue 1 (CI 42090), yellow 5 (CI 19140).

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

SOOTHING SCALP
TREATMENT

antidandruff shampoo
helps control itching and flaking

ANTIDANDRUFF THERAPY®

zinc pyrithione

8 FL.OZ. 240 mL

PROACTIV   SOOTHING SCALP TREATMENT ANTIDANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
DIMETHICONE (UNII: 92RU3N3Y1O)
RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
ROSEMARY (UNII: IJ67X351P9)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 1342 (UNII: 809Y72KV36)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLPARABEN (UNII: A2I8C7HI9T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-162-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	03/01/2012	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 12/2011

Document Id: 517e805f-9d36-4107-83b9-efa8e25f6a88

34390-5

Set id: 890f96ba-4727-4b34-97c9-6b5c279bb65d

Version: 2

Effective Time: 20111212

 

THE PROACTIV COMPANY LLC