Barmicil Plus

Barmicil Plus
SPL v9
SPL
SPL Set ID 850084c3-1dd4-eb8d-e053-2a91aa0a130b
Route
TOPICAL
Published
Effective Date 2019-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Potassium Sorbate Light Mineral Oil Sodium Cetostearyl Sulfate White Petrolatum White Wax Aloe Vera Leaf Cetostearyl Alcohol Water Sodium Benzoate Sodium Lauryl Sulfate Glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-10

Description

Hydrocortisone 1 %

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1 %

Uses

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

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

temporarily relieves external anal and genital itching

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

Label

Barmicil ® plus

with Aloe Vera

1% Hydrocortisone Anti-Itch Cream

Net Wt. 1 0z (28g)

Maximum Strenght Cream

  • Inflammation & Redness
  • Skin Irritation & Rashes
  • Insect Bites, Poison Ivy
  • Eczema & Psoriasis

Made for RRX

San Diego, CA

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Warnings

For external use only

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

when practical, cleanse the affected area with mild soap and 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 applying.

for external anal itching in children under 12 years: ask a doctor

Do Not Use

for the treatment of diaper rash. Ask a doctor.

for external genital itching if you have a vaginal discharge. Ask a doctor.

for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

Questions?

call 619-600-5632

Active Ingredient

Hydrocortisone 1 %

Other Information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive Ingredient

Aloe Vera Leaf Extract, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax.

When Using This Product

do not get into the eyes

for external anal itching, do not use more than directed unless told to do so by a doctor

do not put into the rectum by using fingers or any mechanical device or applicator

Stop Us and Ask Doctor If

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

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

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

temporarily relieves external anal and genital itching

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

Label

Barmicil ® plus

with Aloe Vera

1% Hydrocortisone Anti-Itch Cream

Net Wt. 1 0z (28g)

Maximum Strenght Cream

  • Inflammation & Redness
  • Skin Irritation & Rashes
  • Insect Bites, Poison Ivy
  • Eczema & Psoriasis

Made for RRX

San Diego, CA

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Purpose

Anti-Itch

Warnings

For external use only

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

when practical, cleanse the affected area with mild soap and 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 applying.

for external anal itching in children under 12 years: ask a doctor

Do Not Use (Do not use)

for the treatment of diaper rash. Ask a doctor.

for external genital itching if you have a vaginal discharge. Ask a doctor.

for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

Questions?

call 619-600-5632

Active Ingredient

Hydrocortisone 1 %

Other Information (Other information)

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive Ingredient (Inactive ingredient)

Aloe Vera Leaf Extract, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax.

When Using This Product (When using this product)

do not get into the eyes

for external anal itching, do not use more than directed unless told to do so by a doctor

do not put into the rectum by using fingers or any mechanical device or applicator

Stop Us and Ask Doctor If (Stop us and ask doctor if)

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

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.


Advanced Ingredient Data


Raw Label Data

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