Label: DR BUTLER DIAPER RASH- dimethicone 1% cream
- NDC Code(s): 70942-259-03
- Packager: Beyond Health P.A.
- 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 March 22, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Water, glycerin, petrolatum, panthenol, stearyl alcohol, steareth-20, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel oil, sodium hyaluronate, hamamelis virginiana (witch hzael) leaf extract, rosmarinus officinalis (rosemary) leaf extract, claendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, curcuma longa (tumeric) root extract, olea europaea (olive) leaf extract, lavandula angustifolia (lavender) flower extract, helichrysum italicum extract, centella asiatica extract, panax ginseng root extract, aesculus hippocastanum (horse chestnut) extract, melaleuca alternifolia (tea tree) leaf extract, carya ovata bark extract, avena sativa (oat) kernel extract, cucumis sativus (cucumber) fruit extract, sorbitol, lecithin, xanthan gum, oleic acid, iron oxides (CI 77491), phenoxyethanol, ethylhexylglycerin, sodium chloride, colloidal oatmeal, 4-t-butylcyclohexanol, pentylene glycol, benzalkonium chloride, ceramide NP.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR BUTLER DIAPER RASH
dimethicone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70942-259 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE 350 (UNII: 2Y53S6ATLU) (DIMETHICONE 350 - UNII:2Y53S6ATLU) DIMETHICONE 350 1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) SORBITOL (UNII: 506T60A25R) CARYA OVATA BARK (UNII: X765CF609L) SODIUM CHLORIDE (UNII: 451W47IQ8X) OATMEAL (UNII: 8PI54V663Y) CUCUMBER (UNII: YY7C30VXJT) PETROLATUM (UNII: 4T6H12BN9U) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C) PENTYLENE GLYCOL (UNII: 50C1307PZG) CHAMOMILE (UNII: FGL3685T2X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STEARETH-20 (UNII: L0Q8IK9E08) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) ROSEMARY (UNII: IJ67X351P9) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) OAT KERNEL OIL (UNII: 3UVP41R77R) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) ASIAN GINSENG (UNII: CUQ3A77YXI) HORSE CHESTNUT (UNII: 3C18L6RJAZ) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7) CERAMIDE NP (UNII: 4370DF050B) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24) FERRIC OXIDE RED (UNII: 1K09F3G675) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) OLEIC ACID (UNII: 2UMI9U37CP) TURMERIC (UNII: 856YO1Z64F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70942-259-03 85 g in 1 CAN; Type 0: Not a Combination Product 03/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 03/22/2023 Labeler - Beyond Health P.A. (026781064) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(70942-259)