Neilmed Hydrocortisone 1% Cream With Aloe Anti-itch

Neilmed Hydrocortisone 1% Cream With Aloe Anti-itch
SPL v4
SPL
SPL Set ID 032b9f58-5f64-04dd-e063-6294a90a6bb9
Route
TOPICAL
Published
Effective Date 2023-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10.2 mg)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Isopropyl Myristate Methylparaben Water Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Isostearyl Neopentanoate Peg-40 Monostearate Cetyl Palmitate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-18

Description

Active Ingredients Hydrocortisone, USP 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Active Ingredients Hydrocortisone, USP 1%

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

■ jewelry ■ detergents ■ cosmetics ■ psoriasis ■ seborrheic dermatitis ■ for external genital, feminine and anal itching ■ other uses of this product should be only 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 ■ for external feminine itching if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

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

For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor

Drug Facts

Active Ingredients Hydrocortisone, USP 1%

Other Information:

■ 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 concentrate, benzyl alcohol, ceteareth 20, cetearyl alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

When Using This Product

■ avoid contact with the eyes ■ do not begin the use of any other hydrocortisone product unless directed by a doctor ■ for external anal itching: ■ do not use more than directed unless directed by 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

■ symptoms last for more than 7 days. ■ the condition gets worse ■ symptoms clear up and occur again in a few days ■ rectal bleeding occurs, consult doctor promptly.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222


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

■ jewelry ■ detergents ■ cosmetics ■ psoriasis ■ seborrheic dermatitis ■ for external genital, feminine and anal itching ■ other uses of this product should be only 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)

Purpose

Anti-itch

Warnings:

For external use only Do not use ■ for external feminine itching if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

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

For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor

Drug Facts

Active Ingredients Hydrocortisone, USP 1%

Other Information: (Other information:)

■ 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 concentrate, benzyl alcohol, ceteareth 20, cetearyl alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

When Using This Product (When using this product)

■ avoid contact with the eyes ■ do not begin the use of any other hydrocortisone product unless directed by a doctor ■ for external anal itching: ■ do not use more than directed unless directed by 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 (Stop use and ask a doctor if)

■ symptoms last for more than 7 days. ■ the condition gets worse ■ symptoms clear up and occur again in a few days ■ rectal bleeding occurs, consult doctor promptly.

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

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222


Advanced Ingredient Data


Raw Label Data

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