- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
WARNINGS: For external use only. Avoid contact with eyes. Discontinue use If conditions persist more than 7 days and consult a physician. Do not use on children under 2 years except under the advice and supervision of a physician. Do not use with any other hydrocortisone product unless you have consulted a doctor. Other uses or this product should be only under the advise or supervision of a doctor.
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITCH RELIEF CREAM
hydrocortisone cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MINERAL OIL (UNII: T5L8T28FGP) BENZOIC ACID (UNII: 8SKN0B0MIM) METHYLPARABEN (UNII: A2I8C7HI9T) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-370-09 0.9 g in 1 PACKET; Type 0: Not a Combination Product 11/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/29/2016 Labeler - Cintas Corporation (056481716) Registrant - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(42961-370) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(42961-370)