Label: AVEENO ECZEMA THERAPY ITCH RELIEF BALM- oatmeal cream
- NDC Code(s): 69968-0419-1, 69968-0419-2
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 9, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
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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
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PRINCIPAL DISPLAY PANEL - 312 g Jar Label
NEW LOOK
SAME GREAT FORMULA
Aveeno ®
Eczema
Therapyitch relief balm
colloidal oatmeal • skin protectant creamSoothes Itchy Skin
Immediate itch relief that
lasts on eczema- prone skin
Steroid-free • fragrance-freeACCEPTED
e
NATIONALECZEMA.ORGNATIONAL
ECZEMA
ASSOCIATIONwith
COLLOIDAL
OATMEAL
& CERAMIDEnet wt. 11 oz (312 g)
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INGREDIENTS AND APPEARANCE
AVEENO ECZEMA THERAPY ITCH RELIEF BALM
oatmeal creamProduct 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. (118772437)