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, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, p-Anisic Acid, Caprylic/Capric Triglyceride, Sodium Hydroxide, Avena Sativa (Oat) Kernel Oil, Ceramide NP, Citric Acid, Avena Sativa (Oat) Kernel Extract

Questions or comments?

Call toll-free 866-4-AVEENO (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

NET WT. 11 OZ (312 g)

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

PEDIATRICIAN
RECOMMENDED
BRAND

INGREDIENTS AND APPEARANCE

AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0540
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
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Isocetyl Alcohol (UNII: 1800H64066)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Benzyl Alcohol (UNII: LKG8494WBH)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Cetostearyl Sulfate (UNII: 7ZBS06BH4B)
Benzoic Acid (UNII: 8SKN0B0MIM)
Stearic Acid (UNII: 4ELV7Z65AP)
Dibasic Potassium Phosphate (UNII: CI71S98N1Z)
Potassium Phosphate, Unspecified Form (UNII: B7862WZ632)
p-Anisic Acid (UNII: 4SB6Y7DMM3)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Sodium Hydroxide (UNII: 55X04QC32I)
Oat Kernel Oil (UNII: 3UVP41R77R)
Ceramide NP (UNII: 4370DF050B)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Oat (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0540-5	156 g in 1 JAR; Type 0: Not a Combination Product	03/25/2019
2	NDC: 69968-0540-1	312 g in 1 JAR; Type 0: Not a Combination Product	03/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	03/25/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)