AVEENO BABY CALMING COMFORT- dimethicone lotion

Aveeno Baby Calming Comfort by

Drug Labeling and Warnings

Aveeno Baby Calming Comfort by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin protectant

Uses

• Temporarily protects and helps relieve 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 right away.

Directions

• Apply as needed.

Other information

• Store at room temperature.
• Remove quality seal. Do not use if quality seal is broken.

Inactive ingredients

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

Questions?

Call toll-free 866-4AVEENO (866-428-3366) or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

Aveeno
Baby®

PEDIATRICIAN
Aveeno®
RECOMMENDED®

LAVENDER & VANILLA SCENTED
Calming Comfort® Lotion

with Natural Colloidal Oatmeal
Dimethicone Skin Protectant
Paraben-free, Phthalate-free
Helps Protect Delicate Skin
Moisturizes for 24 Hours
Helps Calm Babies before Bedtime

18 FL. OZ. (532 mL)

INGREDIENTS AND APPEARANCE

AVEENO BABY CALMING COMFORT 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0440
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)
Oat (UNII: Z6J799EAJK)
Benzyl Alcohol (UNII: LKG8494WBH)
Sodium Chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0440-8	227 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2012
2	NDC: 69968-0440-1	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	09/01/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)