ITCH FIXER- hydrocortisone cream

Itch Fixer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations 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 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 condition worsens If symptoms persist for more than 7 days or clear up and reoccur, discontinue use of

this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Keep out of the reach of children.

Do not use if pregnant or breastfeeding.

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 with external anal itching: consult a doctor.

Other information 

Store at a controlled room temperature 68°–77°F (20°–25°C).

Inactive Ingredients

Aqua, Aloe Vera Oil, Benzoic Acid, Cetostearyl Alcohol, Glyceryl Stearate, Jojoba Oil, Polysorbate 80, Oleyl Alcohol, Sorbic Acid, Sorbitan Monooleate

SPL UNCLASSIFIED SECTION

1% Hydrocortisone Anti-Itch Cream

FREE FROM

      x

Petrolatum

Parabens

Sulfates

Mineral Oil

Fragrance

FRAGRANCE FREE

KID FRIENDLY

MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING

SQUEAKY CLEAN FIRST AID

Formulated with naturally derived plant-based ingredients

ALOE VERA known to help soothe skin

JOJOBA OIL known to help moisturize skin

HELPS PROVIDE TEMPORARY ITCH RELIEF FROM

skin irritation

rashes

insect bites 

poison ivy

eczema

Packaging is recyclable.

Distributed by Welly Health PBC

Minneapolis, MN 55402

1-833-BE-WELLY | getwelly.com

Product of USA and Canada with globally sourced materials.

Packaging

INGREDIENTS AND APPEARANCE

ITCH FIXER 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-493
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
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
JOJOBA OIL (UNII: 724GKU717M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-493-66	1 in 1 CARTON	10/01/2021
1		57 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	10/01/2021

Labeler - Welly Health PBC (116766884)