SPL v1
SPL
SPL Set ID 0965a0ed-c8a2-4ce8-a873-287a60078d47
Route
TOPICAL
Published
Effective Date 2019-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Aluminum Sulfate Yellow Wax Calcium Acetate Cetostearyl Alcohol Icodextrin Glycerin Maltodextrin Methylparaben Mineral Oil Petrolatum Propylparaben Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-22

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 50565-1

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

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.
Active Ingredient

Hydrocortisone 1.0%

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

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.
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.
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.
Children Under 2 Years of Age
  • do not use. Consult a doctor.
Adults and Children 2 Years and Older
  • apply to affected area not more than 3 to 4 times daily.
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)


Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Anti-itch

Warnings

For external use only

Do Not Use (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.
Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Other Information (Other information)

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

Inactive Ingredients (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

When Using This Product (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.
For External Anal Itching: (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.
Stop Use and Ask A Doctor If (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.
Children Under 2 Years of Age (Children under 2 years of age)
  • do not use. Consult a doctor.
Adults and Children 2 Years and Older (Adults and children 2 years and older)
  • apply to affected area not more than 3 to 4 times daily.
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)


Advanced Ingredient Data


Raw Label Data

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