Rugby®

Rugby®
SPL v5
SPL
SPL Set ID b2674075-aaa4-4c77-bcaa-a76336b3c321
Route
TOPICAL
Published
Effective Date 2024-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Aloe Vera Leaf Carboxypolymethylene Cetyl Alcohol Dmdm Hydantoin Glyceryl Monostearate Isopropyl Alcohol Methylparaben Mineral Oil Polysorbate 20 Propylparaben Water Stearic Acid Trolamine Edetate Trisodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-14

Description

Drug Facts

Purpose

Antipruritic (anti-itch)

How Supplied

Product: 50090-5470 NDC: 50090-5470-0 28 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Antipruritic (anti-itch)

How Supplied

Product: 50090-5470

NDC: 50090-5470-0 28 g in a TUBE / 1 in a CARTON

Description

Drug Facts

Uses
  • for the 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
  • and for external anal and genital itching.
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 (1-800-222-1222) right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only.

Avoid contact with eyes.

Directions

For itching associated with minor skin irritations, inflammation, and rashes:

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: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Do Not Use
  • if you have a vaginal discharge. Consult a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information

Store at 15 to 30°C (59 to 86°F).

Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions Or Comments?

1-800-645-2158

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Hydrocortisone With Aloe
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • bleeding occurs

Structured Label Content

Uses
  • for the 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
  • and for external anal and genital itching.
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 (1-800-222-1222) right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antipruritic (anti-itch)

Warnings

For external use only.

Avoid contact with eyes.

Directions

For itching associated with minor skin irritations, inflammation, and rashes:

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: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Do Not Use (Do not use)
  • if you have a vaginal discharge. Consult a doctor.
How Supplied (HOW SUPPLIED)

Product: 50090-5470

NDC: 50090-5470-0 28 g in a TUBE / 1 in a CARTON

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

Store at 15 to 30°C (59 to 86°F).

Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions Or Comments? (Questions or comments?)

1-800-645-2158

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Hydrocortisone With Aloe (HYDROCORTISONE WITH ALOE)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • bleeding occurs

Advanced Ingredient Data


Raw Label Data

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