Label: DITCH THE ITCH- colloidal oatmeal cream
- NDC Code(s): 82960-042-01
- Packager: Rosemont Ventures, 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 September 18, 2022
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- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
Allantoin, Aloe Barbadensis (Aloe) Leaf Extract, Aqua (Water), Azadirachta Indica (Neem) Seed Oil, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Caprylic/Capric Triglyceride, Citric Acid, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Gluconolactone, Glycerin, Glyceryl Stearate SE, Kaolin, Potassium Sorbate, Sodium Benzoate, Squalane, Stearyl Alcohol, Xanthan Gum, Zea Mays (Corn) Starch†, Zinc Oxide
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INGREDIENTS AND APPEARANCE
DITCH THE ITCH
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82960-042 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 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) LEVOMENOL (UNII: 24WE03BX2T) CALCIUM GLUCONATE (UNII: SQE6VB453K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) KAOLIN (UNII: 24H4NWX5CO) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XANTHAN GUM (UNII: TTV12P4NEE) SHEA BUTTER (UNII: K49155WL9Y) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SQUALANE (UNII: GW89575KF9) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STARCH, CORN (UNII: O8232NY3SJ) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82960-042-01 1 in 1 CARTON 09/15/2022 1 59 mL 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 M016 09/15/2022 Labeler - Rosemont Ventures, Inc. (933509465) Establishment Name Address ID/FEI Business Operations Monarch PCM, LLC 080000294 manufacture(82960-042)