Label: ITCH RELIEF- hydrocortisone 1% cream
- NDC Code(s): 69396-057-01
- Packager: Trifecta Pharmaceuticals USA LLC
- 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 January 17, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Keep out of Reach of Children
-
Uses
For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to
- Eczema
- Insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- sunburn
- temporarily relieves external anal and genital itching.
Other uses of this product should be only under the advice and supervision of a doctor
- Warnings
- When using this Product
- Stop Using this product and ask a doctor if
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Directions
For itching or skin irritations, inflammation, and rashes.
Adults and children 2 years and older
- Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age
- ask a doctor.
For External and Anal Itching
- Adults: When practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- Children under 12 years of age: ask a doctor
- Other Information
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Inactive Ingredients
Aloe Barbadensis leaf juice, cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, Glycerin, Glyceryl stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2- Phenoxyethyl alcohol, Polysorbate 80, Propylene glycol, purified water, Stearic acid, Trisodium citrate dihydrate, Vitamin E.
- Questions
- Other Information
- Packaging
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INGREDIENTS AND APPEARANCE
ITCH RELIEF
hydrocortisone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength 3-METHYLPENTADECANE (UNII: X64R3JC095) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) GLYCERIN (UNII: PDC6A3C0OX) GINGER OIL (UNII: SAS9Z1SVUK) MALTODEXTRIN (UNII: 7CVR7L4A2D) CETYL ALCOHOL (UNII: 936JST6JCN) EDETIC ACID (UNII: 9G34HU7RV0) METHYL GLUCETH-20 (UNII: J3QD0LD11P) ETHYLPARABEN (UNII: 14255EXE39) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-057-01 1 in 1 BOX 09/17/2020 1 28 g 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 not final part348 09/15/2020 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)