AVEENO ECZEMA THERAPY ITCH RELIEF BALM- oatmeal cream

Aveeno Eczema Therapy Itch Relief Balm by

Drug Labeling and Warnings

Aveeno Eczema Therapy Itch Relief Balm 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 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?

866-428-3366; 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 - 312 g Jar Label

 NEW LOOK
SAME GREAT FORMULA
Aveeno®
Eczema
Therapy

itch relief balm
colloidal oatmeal skin protectant cream

Soothes Itchy Skin

Immediate itch relief that
lasts on eczema- prone skin
Steroid-free fragrance-free

ACCEPTED
e
NATIONALECZEMA.ORG

 NATIONAL
 ECZEMA
 ASSOCIATION

with
COLLOIDAL
OATMEAL
& CERAMIDE

 net wt. 11 oz (312 g)

INGREDIENTS AND APPEARANCE

AVEENO ECZEMA THERAPY ITCH RELIEF BALM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0419
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: 69968-0419-2	28 g in 1 JAR; Type 0: Not a Combination Product	09/01/2016
2	NDC: 69968-0419-1	312 g in 1 JAR; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	09/01/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)