Proactiv Solution Herbal Conditioning TreatmentAntidandruff Conditioner

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 HERBAL CONDITIONING TREATMENT- pyrithione zinc 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 Herbal Conditioning Treatment
Antidandruff Conditioner

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Pyrithione Zinc 0.3%

Purpose

Antidandruff

Use

For the relief of itching and flaking associated with dandruff

Warnings

OTC - DO NOT USE SECTION

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.
• After shampooing, apply to wet hair and massage into scalp.
• 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), cyclomethicone, polyquaternium-37, panthenol, dicetyldimonium chloride, aloe barbadensis leaf extract, helianthus annuus (sunflower) extract, calendula officinalis flower extract, chamomilla recutita (matricaria) extract, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grape) leaf extract, lonicera caprifolium (honeysuckle) flower extract, phenyl trimethicone, amodimethicone, cetrimonium chloride, trideceth-12, sodium PCA, phenoxyethanol, ethylparaben, methylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Carton

Rodan & Fields

proactiv®
SOLUTION

Herbal Conditioning
Treatment

antidandruff conditioner

Antidandruff Therapy®
pyrithione zinc

8 FL. OZ. 240 mL

PROACTIV  HERBAL CONDITIONING TREATMENT
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	3 mg  in 1000 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-309-20	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/1999	01/01/2019
2	NDC: 11410-309-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/1999	01/01/2019
3	NDC: 11410-309-81	1 in 1 BOX	12/01/1999	01/01/2019
3	NDC: 11410-309-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/01/1999	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: 281723df-ef42-4b51-9caa-32888fb17434

34390-5

Set id: 4774fc71-a859-4702-8bd6-f7a66cb75078

Version: 2

Effective Time: 20200127

 

THE PROACTIV COMPANY LLC