AVEENO ACTIVE NATURALS SKIN RELIEF MEDICATED ANTI ITCH TREATMENT- pramoxine hydrochloride cream 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

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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Drug Facts

Active ingredient(s)

Pramoxine HCl (0.5%)

Purpose

External Analgesic

Uses

  • For the temporary relief of itching associated with minor skin irritations.

Warnings

  • For external use only.

  • Avoid contact with eyes.

  • If condition worsens, or if symptoms last more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.

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

Directions

  • Adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other information

Store at room temperature

Inactive ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Menthyl Lactate, Avena Sativa (Oat) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Avena Sativa (Oat) Kernel Extract, Sodium Chloride

Questions?

Call 1-866-428-3366 or www.aveeno.com

Distributed in the US by:

JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY

Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 156g Tube Carton

New
Aveeno®
ACTIVE NATURALS®

skin relief
medicated anti-itch treatment

with cooling action

pramoxine hydrochloride
topical analgestic

acts immediately to
relieve itching
helps prevent
recurring dryness
steroid free

CLINICALLY TESTED
MEDICATED
TRIPLE OAT FORMULA™

net wt. 5.5 oz. (156g)

PRINCIPAL DISPLAY PANEL - 156g Tube Carton
AVEENO ACTIVE NATURALS SKIN RELIEF MEDICATED ANTI ITCH TREATMENT 
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0036
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Distearyldimonium Chloride 
Petrolatum 
Isopropyl Palmitate 
Cetyl Alcohol 
Dimethicone 
Oatmeal 
Benzyl Alcohol 
Chlorphenesin 
Steareth-20 
menthyl Lactate 
Oat Kernel Oil 
Shea Butter 
Oat 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:58232-0036-11 in 1 CARTON
1156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/07/2011
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 09/2011
Document Id: 77e6aeed-c95f-4955-836e-d9565d109654
Set id: 303b3368-46f8-43cf-b78b-fd3e2c83209e
Version: 1
Effective Time: 20110908
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.