- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external feminine, genital and anal itching.
Other uses of this product should be only under the advice and supervision of a doctor.
-
Warnings
For external use only
Do not use
- for the treatment of diaper rash, consult a doctor.
- for external genital itching if you have a vaginal discharge, consult a doctor.
When using this product
- avoid contact with 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.
-
Directions
For external anal itching:
- adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- children under 12 years of age with external anal itching: consult a doctor.
- Other information
- Inactive ingredients
- Principal Display Panel – Can Label
- Principal Display Panel – 0.57oz Tube Label
-
INGREDIENTS AND APPEARANCE
WELLY ITCH FIX
hydrocortisone anti itch cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72663-155 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM SULFATE (UNII: 34S289N54E) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM ACETATE (UNII: Y882YXF34X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ICODEXTRIN (UNII: 2NX48Z0A9G) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72663-155-50 2 in 1 CAN 02/22/2019 1 16 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 02/22/2019 Labeler - Welly Health PBC (116766884) Registrant - Welly Health PBC (116766884) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(72663-155)