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

SPL UNCLASSIFIED SECTION

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

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

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

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 (watercress) 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

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

PROACTIV SOOTHING SCALP TREATMENT ANTIDANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-406
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-406-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/1998	01/01/2019
2	NDC:11410-406-81	1 in 1 BOX	12/01/1998	01/01/2019
2	NDC:11410-406-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	12/01/1998	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: 9b651dbb-e393-4a95-ab1b-bca1c53aa567

Set id: 75b33f17-b304-4b3b-ba3d-bda2730a918b

Version: 2

Effective Time: 20200128

THE PROACTIV COMPANY LLC