AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM- oatmeal cream

Aveeno Baby Eczema Therapy Nighttime Balm by

Drug Labeling and Warnings

Aveeno Baby Eczema Therapy Nighttime Balm by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

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

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.

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

• Do not use if quality seal is broken or missing.
• Protect from Excessive Heat (40°C/104°F).

Inactive Ingredients

Glycerin, Water ,Cetearyl Alcohol, Isocetyl Alcohol, Dimethicone, Cetyl Alcohol, Ethylhexylglycerin, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Ceramide NP, Caprylic/Capric Triglyceride, Sodium Cetearyl Sulfate, Potassium Phosphate, Dipotassium Phosphate, Stearic Acid, Sodium Hydroxide, Citric Acid, Benzyl Alcohol, p –Anisic Acid, Benzoic Acid.

Questions or Comments?

Call toll-free 866-4AVEENO (866-428-3366) or 215-273-8755 (collect)

www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 312 g Jar Label

Aveeno
Baby®

Eczema
Therapy

NIGHTTIME BALM
colloidal oatmeal . skin protectant cream

Steroid-free . Fragrance-free . Paraben-free .
Phthalate-free . Hypoallergenic
Specially formulated to provide immediate
and long-lasting moisture through the night.

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

PEDIATRICIAN
RECOMMENDED
BRAND

NET WT. 11 OZ (312g)

INGREDIENTS AND APPEARANCE

AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0369
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Isocetyl Alcohol (UNII: 1800H64066)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Ethylhexylglycerin (UNII: 147D247K3P)
Oat Kernel Oil (UNII: 3UVP41R77R)
Oat (UNII: Z6J799EAJK)
Ceramide NP (UNII: 4370DF050B)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Sodium Cetostearyl Sulfate (UNII: 7ZBS06BH4B)
Potassium Phosphate, Unspecified Form (UNII: B7862WZ632)
Dibasic Potassium Phosphate (UNII: CI71S98N1Z)
Stearic Acid (UNII: 4ELV7Z65AP)
Sodium Hydroxide (UNII: 55X04QC32I)
Benzyl Alcohol (UNII: LKG8494WBH)
p-Anisic Acid (UNII: 4SB6Y7DMM3)
Benzoic Acid (UNII: 8SKN0B0MIM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0369-1	28 g in 1 JAR; Type 0: Not a Combination Product	12/01/2017	02/11/2021
2	NDC: 69968-0369-2	312 g in 1 JAR; Type 0: Not a Combination Product	12/01/2017	01/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2017	02/11/2021

Labeler - Johnson & Johnson Consumer Inc. (002347102)