neilmed hydrocortisone ointment anti itch 1 oz

neilmed hydrocortisone ointment anti itch 1 oz
SPL v3
SPL
SPL Set ID 031957e1-9b0c-1579-e063-6394a90aaee8
Route
topical
Published
Effective Date 2023-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (0.0102 g)
Inactive Ingredients
mineral oil petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-08-17

Purpose

Anti-Itch

Description

Active Ingredients Hydrocortisone, USP 1%


Medication Information

Purpose

Anti-Itch

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

Other Information

Before using any medication, read all label directions.

Keep carton, it contains important information.

Inactive Ingredients

mineral oil, white petrolatum.

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 44425-7

Storage temperature: not to exceed 30°C (86°F).

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.

Drug Facts

Active Ingredients

Hydrocortisone, USP 1%

Keep Out of Reach of Children.

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

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


Structured Label Content

Purpose

Anti-Itch

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

Other Information (Other information)

Before using any medication, read all label directions.

Keep carton, it contains important information.

Inactive Ingredients (Inactive ingredients)

mineral oil, white petrolatum.

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 44425-7 (44425-7)

Storage temperature: not to exceed 30°C (86°F).

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:

􀀃for external feminine itching if you have a vaginal discharge. Consult a doctor.

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

Drug Facts

Active Ingredients

Hydrocortisone, USP 1%

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

Stop Use and Ask A Doctor If : (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


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