OTC Medication Information: Aveeno Baby Eczema Therapy Soothing Bath Treatment

AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT- oatmeal powder
Johnson & Johnson Consumer 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.

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?

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

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

PRINCIPAL DISPLAY PANEL — 213 g Packet Carton

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTS

Aveeno ®

baby

NEW

LOOK
Same Great
Formula

eczema therapy

soothing bath treatment

colloidal oatmeal skin protectant

relieves dry, itchy,
irritated skin due to:
eczema, rashes,
poison ivy/oak/sumac,
insect bites

fragrance-free, allergy tested,
tear-free, steroid free

ACCEPTED
NATIONALECZEMA.ORG

National
Eczema
Association

10 Bath Packets

TOTAL NET WT. 7.5 OZ. (213 g)

PRINCIPAL DISPLAY PANEL -- 213 g Packet Carton
(click image for full-size original)
AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT
oatmeal powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0541
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (OATMEAL) OATMEAL 430 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
CALCIUM SILICATE
LAURETH-4
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0541-1 10 PACKET in 1 CARTON contains a PACKET
1 21 g in 1 PACKET This package is contained within the CARTON (69968-0541-1)
2 NDC:69968-0541-3 5 PACKET in 1 CARTON contains a PACKET
2 21 g in 1 PACKET This package is contained within the CARTON (69968-0541-3)
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. (118772437)

Revised: 05/2023 Johnson & Johnson Consumer Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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