Label: AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT- oatmeal powder
- NDC Code(s): 69968-0541-1, 69968-0541-3
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated May 2, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 213 g Packet Carton
RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTSAveeno ®
baby
NEW
LOOK
Same Great
Formulaeczema
therapysoothing bath treatment
colloidal oatmeal
skin protectantrelieves dry, itchy,
irritated skin due to:
eczema, rashes,
poison ivy/oak/sumac,
insect bitesfragrance-free, allergy tested,
tear-free, steroid freeACCEPTED
NATIONALECZEMA.ORGNational
Eczema
Association10 Bath Packets
TOTAL NET WT. 7.5 OZ. (213 g)
-
INGREDIENTS AND APPEARANCE
AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT
oatmeal powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0541 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:69968-0541-1 10 in 1 CARTON 03/25/2019 05/01/2025 1 21 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69968-0541-3 5 in 1 CARTON 01/01/2012 2 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. (118772437)