AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT- oatmeal powder

Aveeno Baby Eczema Therapy Soothing Bath Treatment by

Drug Labeling and Warnings

Aveeno Baby Eczema Therapy Soothing Bath Treatment 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

Colloidal oatmeal 43%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

• Rashes
• Eczema
• Poison ivy, oak or sumac
• Insect bites

Warnings

For external use only.

When using this product

• Do not get into eyes.
• To avoid slipping, use mat in tub or shower.
• In some skin conditions, soaking too long may overdry.

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 right away.

Directions

For dispersal in water:

• Turn warm water faucet on to full force.
• Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container.
• Stir any colloidal oatmeal settled on the bottom.

For use as a soak in a bath:

• Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom.
• Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor.
• Pat dry (do not rub) to keep a thin layer on the skin.

Other information

Store at room temperature.

Inactive ingredients

mineral oil, calcium silicate, laureth-4

Questions?

866-4AVEENO; 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 - 106 g Packet Carton

PEDIATRICIAN RECOMMENDED BRAND

Aveeno
Baby®
Eczema
Therapy
SOOTHING
BATH TREATMENT
colloidal oatmeal skin protectant
Steroid-free, Fragrance free, Paraben-free, Phthalate-free
Relieves Dry, Itchy, Irritated skin due to:
Rashes, Eczema, Poison Ivy/Oak/Sumac, Insect Bites
National
Eczema
Association
ACCEPTED
NATIONALECZEMA.ORG

5 Bath Packets TOTAL NET WT. 3.75 OZ. (106g)

INGREDIENTS AND APPEARANCE

AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT 
oatmeal powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	430 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Mineral Oil (UNII: T5L8T28FGP)
Calcium Silicate (UNII: S4255P4G5M)
Laureth-4 (UNII: 6HQ855798J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0199-5	5 in 1 CARTON	01/01/2012
1		21 g in 1 PACKET; Type 0: Not a Combination Product

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

Labeler - Johnson & Johnson Consumer Inc. (002347102)