Proactiv Solution Anti-Itch Scalp Spray

Proactiv Solution Anti-Itch Scalp by

Drug Labeling and Warnings

Proactiv Solution Anti-Itch Scalp by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SOLUTION ANTI-ITCH SCALP- hydrocortisone liquid 
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.

----------

Proactiv Solution Anti-Itch Scalp Spray

Drug Facts

Active Ingredient

Hydrocortisone 0.28%

Purpose

Anti-Itch

Uses

• temporarily relieves scalp itching associated with minor skin irrations, inflammation and rashes due to:
  • seborrheic dermatitis
  • psoriasis
  • eczema
  • soaps
  • cosmetics
  • insect bites
  • poison ivy, oak, sumac
• other uses of this product should only be used under the advice and supervision of a doctor.

Warnings

For external use only

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

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.

When using this product

• use only as directed
• do not exceed recommended daily dosage unless directed by a doctor
• do not cover treated skin
• consult a doctor before use if you are using any other hydrocortisone products
• keep away from the eyes
• if contact with eyes occurs, flush liberally with water.

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

• adults and children 2 years of age and older – apply to affected scalp area only, no more than 3-4 times daily.
• part hair and lightly spray directly onto the affected area.
• be sure the solution reaches the scalp and the entire area is covered.
• can gently spread over the area with fingers.
• wash hands.

Inactive Ingredients

water, alcohol denat., butylene glycol, vitis vinifera (grape) seed extract, camellia oleifera leaf extract, salix alba (willow) bark extract, salicylic acid, leptospermone, isoleptospermone, flavesone, allantoin, methylpropanediol, polysorbate 80, PEG-40 hydrogenated castor oil, fragrance.

Dist by Guthy-Renker® ∙ PO Box 14383 ∙ Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Label

Rodan & Fields

proactiv®
SOLUTION

ANTI-ITCH
SCALP SPRAY

ANTIDANDRUFF THERAPY®

with hydrocortisone

0.5 FL. OZ. 15 mL

PROACTIV SOLUTION ANTI-ITCH SCALP 
hydrocortisone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.28 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
SALIX ALBA BARK (UNII: 205MXS71H7)
ALLANTOIN (UNII: 344S277G0Z)
SALICYLIC ACID (UNII: O414PZ4LPZ)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-602-05	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/07/2010	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/07/2010	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 2/2012

Document Id: 1c452292-6d38-4a35-8fa7-0029d0a4f2b9

34390-5

Set id: f23613e5-a437-4aa4-bbf7-290131463d24

Version: 2

Effective Time: 20120202

 

THE PROACTIV COMPANY LLC