AVEENO BABY SOOTHING RELIEF MOISTURIZING- dimethicone cream

Aveeno Baby Soothing Relief Moisturizing by

Drug Labeling and Warnings

Aveeno Baby Soothing Relief Moisturizing 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

• 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 right away.

Directions

• Twist off cap, remove quality seal. Apply liberally or as needed. Do not use if quality seal is broken

Other information

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, Avena Sativa (Oat) Kernel Oil, Steareth-20, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Avena Sativa (Oat) Kernel Extract

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 226 g Tube Label

Aveeno
Baby®

PEDIATRICIAN
Aveeno®
RECOMMENDED®

FRAGRANCE-FREE
PARABEN-FREE

Soothing Relief
Moisturizing Cream

Dimethicone Skin Protectant
Natural Triple Oat Complex

Clinically Shown to
Soothe & Relieve Dry Sensitive Skin

Moisturizes for 24 Hours

NET WT. 8 OZ. (226 g)

INGREDIENTS AND APPEARANCE

AVEENO BABY SOOTHING RELIEF MOISTURIZING 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0437
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 g

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)
Benzyl Alcohol (UNII: LKG8494WBH)
OAT KERNEL OIL (UNII: 3UVP41R77R)
Steareth-20 (UNII: L0Q8IK9E08)
Sodium Chloride (UNII: 451W47IQ8X)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0437-8	226 g in 1 TUBE; Type 0: Not a Combination Product	10/22/2015
2	NDC: 69968-0437-5	141 g in 1 TUBE; Type 0: Not a Combination Product	10/22/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/22/2015

Labeler - Johnson & Johnson Consumer Inc. (002347102)