AVEENO BABY DAILY MOISTURE- dimethicone lotion

Aveeno Baby Daily Moisture by

Drug Labeling and Warnings

Aveeno Baby Daily Moisture by is a Otc medication manufactured, distributed, or labeled by KDC/ONE Development Corporation, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Dimethicone (1.2%)

Purpose

Skin Protectant

Uses

• Helps prevent and temporarily protects chafed, chapped or cracked skin.

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.

Other Information

• To open, twist off cap and remove quality seal. Do not use if quality seal is broken.
• Store at room temperature.

Inactive ingredients

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

Questions?

Call toll-free 866-4AVEENO or 215-273-8755 (collect) www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS
COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 227 g Tube Label

Aveeno ®

Baby ®

PEDIATRICIAN

RECOMMENDED ®

FRAGRANCE FREE

Daily Moisture Lotion

Dimethicone Skin Protectant

With Natural Colloidal Oatmeal

Protects Delicate Skin

Moisturizes for 24 Hours

NET WT. 8 OZ. (227 g)

INGREDIENTS AND APPEARANCE

AVEENO BABY DAILY MOISTURE 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54565-1303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54565-1303-4	227 mL in 1 TUBE; Type 0: Not a Combination Product	11/07/2017
2	NDC: 54565-1303-2	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/07/2017
3	NDC: 54565-1303-3	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/07/2017
4	NDC: 54565-1303-1	29.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2010

Labeler - Knowlton Development Corporation Inc (204006464)

Establishment
Name	Address	ID/FEI	Business Operations
Knowlton Development Corporation Inc		204006464	manufacture(54565-1303) , analysis(54565-1303) , pack(54565-1303) , label(54565-1303)