Label: NU-DERM TOLEREEN- hydrocortisone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-112-36 - Packager: OMP, Inc.
- Category: HUMAN OTC DRUG LABEL
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 October 26, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
- Eczema
- Psoriasis
- Insect bites
- Seborrheic dermatitis
- Soaps
- Poison ivy
- Poison oak
- Poison sumac
- Jewelry
- Cosmetics
- Detergents
- Other uses of this product should be only under the advice and supervision of a doctor.
- Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
- Warnings
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57g Bottle Carton
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INGREDIENTS AND APPEARANCE
NU-DERM TOLEREEN ANTI-PRURITIC
hydrocortisone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 5 mg in 1 g Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) METHYLPARABEN (UNII: A2I8C7HI9T) ALLANTOIN (UNII: 344S277G0Z) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLPARABEN (UNII: 3QPI1U3FV8) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-112-36 1 in 1 BOX 1 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 01/01/1988 Labeler - OMP, Inc. (790553353) Establishment Name Address ID/FEI Business Operations Puretek Corporation 785961046 MANUFACTURE(62032-112) , LABEL(62032-112) , PACK(62032-112)