Aquaphor Itch Relief Ointment

Aquaphor Itch Relief Ointment
SPL v6
SPL
SPL Set ID b1d0333f-ba60-35d8-e053-2995a90af932
Route
TOPICAL
Published
Effective Date 2022-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
3-((l-menthyl)oxy)propane-1,2-diol Mineral Oil Ceresin Lanolin Alcohols Glycerin Panthenol Levomenol Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-01

Description

Active Ingredient Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema

• insect bites

• soaps

• poison ivy, oak, sumac

• seborrheic dermatitis

• psoriasis

• detergents

• cosmetics

• jewelry

Dosage and Administration

Directions

Adults and children 2 years of age 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.

Description

Active Ingredient Hydrocortisone 1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9

Stop use and consult a doctor if

• condition worsens, if symptoms persist for more than 7 days or clear

up and occur again within a few days,

and do not begin use of any other hydrocortisone product unless you have asked a doctor

Section 50567-7

When using this product

• avoid contact with eyes

• do not exceed the recommended daily dosage unless directed by a doctor

Section 50570-1

Do not use

• for the treatment of diaper rash. Consult a doctor.

Section 51727-6

Inactive ingredients

Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol,

Panthenol, Glycerin, Bisabolol, Menthoxypropanediol

Section 51945-4

Aquaphor Itch Relief Ointment

Maximum Strength

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Skin irritation

Skin rashes

Eczema

Psoriasis

Eczema

Poison Ivy

Children's

Aquaphor Itch Relief Ointment

Ages 2 Years and Older

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

Number 1 Pediatrician Recommended Brand for Eczema

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Eczema

Skin irritation

Skin rashes

Psoriasis

Eczema

Poison Ivy

Section 53413-1

Questions or comments?

1-800-227-4703

Section 55105-1

Purpose

Anti-Itch Ointment

Section 55106-9

Active Ingredient

Hydrocortisone 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema

• insect bites

• soaps

• poison ivy, oak, sumac

• seborrheic dermatitis

• psoriasis

• detergents

• cosmetics

• jewelry

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age 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.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and consult a doctor if

• condition worsens, if symptoms persist for more than 7 days or clear

up and occur again within a few days,

and do not begin use of any other hydrocortisone product unless you have asked a doctor

Section 50567-7 (50567-7)

When using this product

• avoid contact with eyes

• do not exceed the recommended daily dosage unless directed by a doctor

Section 50570-1 (50570-1)

Do not use

• for the treatment of diaper rash. Consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol,

Panthenol, Glycerin, Bisabolol, Menthoxypropanediol

Section 51945-4 (51945-4)

Aquaphor Itch Relief Ointment

Maximum Strength

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Skin irritation

Skin rashes

Eczema

Psoriasis

Eczema

Poison Ivy

Children's

Aquaphor Itch Relief Ointment

Ages 2 Years and Older

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

Number 1 Pediatrician Recommended Brand for Eczema

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Eczema

Skin irritation

Skin rashes

Psoriasis

Eczema

Poison Ivy

Section 53413-1 (53413-1)

Questions or comments?

1-800-227-4703

Section 55105-1 (55105-1)

Purpose

Anti-Itch Ointment

Section 55106-9 (55106-9)

Active Ingredient

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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