SPL v1
SPL
SPL Set ID 14b4f066-fde4-ac97-e063-6394a90ae64c
Route
RECTAL
Published
Effective Date 2024-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Avena Sativa Pollen Icodextrin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Menthyl Lactate, (-)- Edetate Disodium Ppg-3 Benzyl Ether Myristate Dimethicone 1000 Polysorbate 60 Methylparaben Sodium Citrate Propylparaben Glycerin Dehydrated Alcohol Water Isohexadecane Maltodextrin Methyl Gluceth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-21

Description

Active Ingredients Hydrocortisone 1%


Medication Information

Description

Active Ingredients Hydrocortisone 1%

Uses

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

■ eczema

■ insect bites

■ cosmetics

■ psoriasis

■ detergents

■ soaps

■ poison ivy, oak and sumac

■ jewelry

■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should only be under the advice and supervision of a doctor

Section 50741-8

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Section 51945-4

Warnings

For external use only.

Do not use

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash.

Consult a doctor.

Directions

■ for itching of skin irritation, 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: ask a doctor

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



■ for external anal and genital itching,

adults:

■ when practical, clean the affected area with mild soap and warm water and rinse

thoroughly

■ gently dry by patting or blotting with toilet tissue or a soft cloth before

applying

■ apply to affected area not more than 3 to 4 times daily

■ children under 12 years of age: ask a doctor

Do Not Use
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Drug Facts

Active Ingredients

Hydrocortisone 1%

Storage Temperature

not to exceed 30°C (86°F).

Protect from freezing.

■ Before using any medication, read all label directions.

Keep carton, it contains important information.

Inactive Ingredients:

aloe vera leaf, avena sativa extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acrylodimethyl taurate copolymer, isohexadecane, maltodextrin, methyl gluceth-20, methyl lactate, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, purified water, SD alcohol,sodium citrate

When Using This Product
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If



■ condition worsens, 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.

■ rectal bleeding occurs

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison


Structured Label Content

Uses

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

■ eczema

■ insect bites

■ cosmetics

■ psoriasis

■ detergents

■ soaps

■ poison ivy, oak and sumac

■ jewelry

■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should only be under the advice and supervision of a doctor

Section 50741-8 (50741-8)

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Section 51945-4 (51945-4)

Warnings

For external use only.

Do not use

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash.

Consult a doctor.

Directions

■ for itching of skin irritation, 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: ask a doctor

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



■ for external anal and genital itching,

adults:

■ when practical, clean the affected area with mild soap and warm water and rinse

thoroughly

■ gently dry by patting or blotting with toilet tissue or a soft cloth before

applying

■ apply to affected area not more than 3 to 4 times daily

■ children under 12 years of age: ask a doctor

Do Not Use (Do not Use)
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Drug Facts

Active Ingredients

Hydrocortisone 1%

Storage Temperature (Storage temperature)

not to exceed 30°C (86°F).

Protect from freezing.

■ Before using any medication, read all label directions.

Keep carton, it contains important information.

Inactive Ingredients: (Inactive ingredients:)

aloe vera leaf, avena sativa extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acrylodimethyl taurate copolymer, isohexadecane, maltodextrin, methyl gluceth-20, methyl lactate, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, purified water, SD alcohol,sodium citrate

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
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 occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

■ rectal bleeding occurs

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison


Advanced Ingredient Data


Raw Label Data

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