Label: HYDROCORTISONE 1% ANTI-ITCH CREAM- hydrocortisone cream
- NDC Code(s): 24286-1578-1
- Packager: DLC Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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Uses
for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
for external genital, feminine and anal itching
other uses of this product should be only under the advice and supervision of a doctor
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Warnings
For external use only
for the treatment of diaper rash. Consult a doctor.
for external feminine itching if you have a vaginal discharge. Consult a doctor.
When using this product
avoid contact with the eyes
do not use more than directed unless told to do so by a doctor
do not put this product into rectum by using fingers or any methanical devices or applicator
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Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use. Consult a doctor.
Adults: for external anal itching: when practical, cleanse 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 application of this product
Children under 12 years of age: for external anal itching, consult a doctor
- Other information
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Inactive ingredients
Aloe barbadensis (aloe vera), Butyrospermum parkii (shea) butter, C12-15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cetyl alcohol, dimethicone, ethylhexylglycerin, glyceryl stearate, Persea gratissima (avocado) oil, phenoxyethanol, propylene glycol, Prunus amygdalus dulcis (sweet almond) oil, purified water, sodium polyacrylate, sodium stearoyl glutamate, tocopheryl acetate (vitamin E), xanthan gum.
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE 1% ANTI-ITCH CREAM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1578 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 ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.2 g in 100 g SHEA BUTTER (UNII: K49155WL9Y) 1 g in 100 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 10 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) 0.8 g in 100 g SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 0.6 g in 100 g CETYL ALCOHOL (UNII: 936JST6JCN) 2.5 g in 100 g CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) 7 g in 100 g WATER (UNII: 059QF0KO0R) 65.65 g in 100 g C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) 4 g in 100 g ALMOND OIL (UNII: 66YXD4DKO9) 1 g in 100 g SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 0.3 g in 100 g .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g in 100 g CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) 2 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 g in 100 g AVOCADO OIL (UNII: 6VNO72PFC1) 0.1 g in 100 g XANTHAN GUM (UNII: TTV12P4NEE) 0.3 g in 100 g GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2.5 g in 100 g ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 0.05 g in 100 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1578-1 1 in 1 BOX 05/15/2024 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 Drug M017 05/15/2024 Labeler - DLC Laboratories, Inc. (093351930) Establishment Name Address ID/FEI Business Operations DLC Laboratories, Inc. 093351930 manufacture(24286-1578)
