WELLY ITCH FIX- hydrocortisone anti itch cream cream

Welly Itch Fix by

Drug Labeling and Warnings

Welly Itch Fix by is a Otc medication manufactured, distributed, or labeled by Welly Health PBC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

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.

Stop use and ask a doctor if

• If condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

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 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

store at controlled room temperature 68° - 77ºF (20°-25°C).

Inactive ingredients

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

Principal Display Panel – Can Label

Welly First Aid Itch Fix 

NDC: 72663-155-50

Hydrocortisone 1% Anti-itch Cream

2 tubes -0.57 oz(16g)   Total Net Wt 1.14oz (32g)

Principal Display Panel – 0.57oz Tube Label

NDC: 72663-155-50    Welly First Aid Itch fix

Hydrocortisone 1% Anti-itch Cream  Net Wt. 0.57 oz (16g)

INGREDIENTS AND APPEARANCE

WELLY ITCH FIX 
hydrocortisone anti itch cream cream

Product 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)