Label: DERMAL-SOOTHE- pramoxine hydrochloride cream
- NDC Code(s): 17030-042-08, 17030-042-16
- Packager: Vetoquinol USA, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated October 2, 2018
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- SPL UNCLASSIFIED SECTION
- INDICATIONS:
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DESCRIPTION:
Micro Pearls® Advantage Dermal-Soothe™ Anti-Itch Cream Rinse is a remarkable breakthrough in animal care technology. Dermal-Soothe™ Anti-Itch Cream Rinse contains itch-relieving Pramoxine Hydrochloride and Novasome® microvesicles designed to deliver long lasting moisture factors to the hair and epidermal layers in a rich cream rinse base that relieves itching, dry skin and leaves the hair coat soft, supple and lustrous.
- DIRECTIONS:
- ACTIVE INGREDIENTS:
- INACTIVE INGREDIENTS:
- PRECAUTIONS:
- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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INGREDIENTS AND APPEARANCE
DERMAL-SOOTHE
pramoxine hydrochloride creamProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17030-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Citric Acid Monohydrate (UNII: 2968PHW8QP) Oatmeal (UNII: 8PI54V663Y) Dimethicone (UNII: 92RU3N3Y1O) Pork Collagen (UNII: I8442U2G7J) PEG-100 Stearate (UNII: YD01N1999R) Glycol Stearate (UNII: 0324G66D0E) Cetyl Alcohol (UNII: 936JST6JCN) Sodium Stearoamphoacetate (UNII: I9MO470Z8J) Myristalkonium Chloride (UNII: 0W255OL75T) Quaternium-15 (UNII: E40U03LEM0) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17030-042-08 237 mL in 1 BOTTLE, PLASTIC 2 NDC:17030-042-16 474 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/29/1999 Labeler - Vetoquinol USA, Inc. (106824209) Establishment Name Address ID/FEI Business Operations American Pharmaceuticals and Cosmetics, Inc. 038023805 MANUFACTURE Establishment Name Address ID/FEI Business Operations Syn-Tech Chem. & Pharm. Co., Ltd. 656002532 API MANUFACTURE