Itch Fixer

Itch Fixer
SPL v2
SPL
SPL Set ID e0d12acd-6e99-417d-a983-231e13bc1dd2
Route
TOPICAL
Published
Effective Date 2021-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Aloe Vera Leaf Benzoic Acid Cetostearyl Alcohol Glyceryl Monostearate Jojoba Oil Polysorbate 80 Oleyl Alcohol Sorbic Acid Sorbitan Monooleate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-10-01

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

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.

Section 42229-5

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.

Section 50565-1

Keep out of the reach of children.

• Do not use if pregnant or breastfeeding.

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  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.

Packaging

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.

Active Ingredient

Hydrocortisone 1%

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


Structured Label Content

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.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

Keep out of the reach of children.

• Do not use if pregnant or breastfeeding.

Purpose

Anti-itch

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  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.

Packaging

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.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information  (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


Advanced Ingredient Data


Raw Label Data

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