AVEENO - dimethicone lotion 
Physicians Total Care, 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®
Active Naturals™
Daily Moisturizing
LOTION

Drug Facts

Active ingredient

Dimethicone 1.25%

Purposes

Skin Protectant

Uses

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.

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

Directions

Inactive ingredients

Avena Sativa (Oat) Kernel flour, Benzyl Alcohol, Cetyl Alcohol, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Petrolatum, Sodium Chloride, Water

Questions?

1-877-288-2525 or visit www.Aveeno.com

PRINCIPAL DISPLAY PANEL

dermatologist
recommended

Aveeno®
ACTIVE NATURALS®

Daily Moisturizing
LOTION
dimethicone skin protectant

clinically proven to
relieve dry skin

moisturizes for 24 hours
fragrance free

with
natural colloidal oatmeal

18 fl. oz. (532 mL)

NDC 54868-5875-0

image of package label




Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma           74146
AVEENO 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5875(NDC:58232-9907)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Distearyldimonium Chloride (UNII: OM9573ZX3X)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Petrolatum (UNII: 4T6H12BN9U)  
Sodium Chloride (UNII: 451W47IQ8X)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5875-0532 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/31/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 5/2012
Document Id: c88a4047-8d8c-4ce7-911a-4dcd6cb4baf1
Set id: 361ad181-d429-4127-92f5-958d229879b9
Version: 1
Effective Time: 20120521
 
Physicians Total Care, Inc.