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Name:Aveeno Active Naturals Skin Relief Calming
Manufacturer:Johnson & Johnson Consumer Products Company, Division Of Johnson & Johnson Consumer Companies, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Aveeno Skin Relief Calming Lotion

AVEENO ACTIVE NATURALS SKIN RELIEF CALMING - dimethicone 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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Aveeno Skin Relief Calming Lotion

Drug Facts

Active ingredient

Dimethicone 1.3%

Purposes

Skin Protectant

Uses

  • Helps prevent and temporarily protects chafed, chapped, or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only.

When using this product

  • Do not get into eyes

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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

Directions

  • Apply as needed.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 198 g Tube Label

new
Aveeno
®
ACTIVE NATURALS®

skin relief
calming lotion
with cooling action

dimethicone skin protectant

provides immediate and
lasting moisture relief
for itchy, extra-dry skin

steroid free

CLINICALLY TESTED
MEDICATED
TRIPLE OAT FORMULA

net wt. 7.0 oz. (198 g)

PRINCIPAL DISPLAY PANEL - 198 g Tube Label

AVEENO ACTIVE NATURALS SKIN RELIEF CALMING 
dimethicone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58232-0034
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone (Dimethicone) Dimethicone 12.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Distearyldimonium Chloride  
Petrolatum  
Isopropyl Palmitate  
Cetyl Alcohol  
Oatmeal  
Benzyl Alcohol  
Steareth-20  
Chlorphenesin  
Menthol  
Oat Kernel Oil  
Shea Butter  
Oat  
Sodium Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58232-0034-1 198 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 05/01/2011

Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 04/2011 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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