Label: STUDIO35 ECZEMA- colloidal oatmeal cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-4246-11 - Packager: Walgreen Company
- 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 September 10, 2014
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep Out of Reach of Children.
- Directions
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Inactive ingredients
water, glycerin, distearyldimonium chloride, isopropyl palmitate, cetearyl alcohol, petrolatum, dimethicone, steareth-21, panthenol (pro-vitamin B5), benzalkonium chloride, ceramide 3, ceramide 6-ii, ceramide 1, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, xanthan gum, avena sativa (oat) kernel oil, avena sativa (oat) kernel extract, sodium chloride, avena sativa (oat) kernel flour, triethanolamine.
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Package/Label Principal Display Panel
studio35™
COMPARE TO
AVEENO® ACTIVE
NATURALS® ECZEMA
THERAPY MOISTURIZING CREAM*SKIN PROTECTANT
ECZEMA
CREAMWITH NATURAL
COLLOIDAL
OATMEALHELPS TO RELIEVE
DRY, ITCHY SKIN
DUE TO ECZEMASTEROID-FREE &
FRAGRANCE-FREEDERMATOLOGIST TESTED
NET WT 7.3 OZ (207 g)
Enriched with soothing oatmeal, this innovative cream offers relief
to help care for dry, itchy skin, while intensely moisturizing it. It
helps to fortify the skin's natural barrier functions while helping to
prevent the recurrence of dry skin. The formula is enriched with
ceramides, essential lipids naturally found in the skin, to enhance
and restore the skin's natural protective function.*This product is not manufactured or distributed
by Johnson & Johnson®, owner of the registered
trademark Aveeno® Active Naturals®.DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com © 2014 Walgreen Co.
MADE IN ISRAELCarton Label
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INGREDIENTS AND APPEARANCE
STUDIO35 ECZEMA
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4246 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-21 (UNII: 53J3F32P58) PANTHENOL (UNII: WV9CM0O67Z) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM CHLORIDE (UNII: 451W47IQ8X) CERAMIDE 3 (UNII: 4370DF050B) CERAMIDE 6 II (UNII: F1X8L2B00J) CERAMIDE 1 (UNII: 5THT33P7X7) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) XANTHAN GUM (UNII: TTV12P4NEE) OAT KERNEL OIL (UNII: 3UVP41R77R) OAT (UNII: Z6J799EAJK) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4246-11 207 g in 1 TUBE; 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 09/01/2014 Labeler - Walgreen Company (008965063)
