Label: HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream
- NDC Code(s): 0536-1407-95
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
Uses
For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor.
- Keep out of reach of children
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Warnings
- for external use only
- avoid contact with eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator
For External Anal Itching Users:
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- children under 12 years of age: consult a doctor
Before using any medication, read all label directions. Keep this carton as it contains important information
- Do Not Use
- Stop using this product and ask a doctor if
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When using this product
- avoid contact with the eyes.
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
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Directions
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
- Do not use, consult a doctor
For External and anal itching
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
by patting or blotting with toilet tissue or a soft cloth before application of this product.
- adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age with external anal itching: consult a doctor.
- Inactive Ingredients
- Other Information
- Other Information
- Package Label
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE CREAM WITH ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1407 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 GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PETROLATUM (UNII: 4T6H12BN9U) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 60 (UNII: CAL22UVI4M) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1407-95 1 in 1 BOX 03/08/2024 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 03/08/2024 Labeler - Rugby Laboratories (079246066) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)