Gelmicin Hydrocortisone Cream With Aloe 1.41 Oz 64035 Zdp

Gelmicin Hydrocortisone Cream With Aloe 1.41 Oz 64035 Zdp
SPL v4
SPL
SPL Set ID bb64eca4-799d-4711-e053-2995a90af403
Route
TOPICAL
Published
Effective Date 2021-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Calcium Acetate Monohydrate Propylparaben Maltodextrin Methylparaben Propylene Glycol Light Mineral Oil Petrolatum Water Sodium Lauryl Sulfate Aluminium Sulfate Octadecahydrate Cetostearyl Alcohol White Wax Sodium Cetostearyl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-22

Description

Active ingredient Purpose Hydrocortisone 1%..................................................Anti-itch


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • before first use, remove or puncture seal under cap by using the tip of the cap
  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • 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
Dosage and Administration

Distributed by:

Gute Besserung Hauser

San Diego, CA 92154

Made in China

Description

Active ingredient Purpose Hydrocortisone 1%..................................................Anti-itch

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
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 50566-9

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
Section 50567-7

When using this product

  • avoid contact with eyes
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 50570-1

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.
  • more than directed unless directed by a doctor
Section 51727-6

Inactive ingredients

aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison ivy, oak sumac
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advise and supervision of a doctor
Section 55106-9

Active ingredient Purpose

Hydrocortisone 1%..................................................Anti-itch


Structured Label Content

Indications and Usage (34067-9)

Directions

  • before first use, remove or puncture seal under cap by using the tip of the cap
  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • 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
Dosage and Administration (34068-7)

Distributed by:

Gute Besserung Hauser

San Diego, CA 92154

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
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 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 50570-1 (50570-1)

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.
  • more than directed unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison ivy, oak sumac
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advise and supervision of a doctor
Section 55106-9 (55106-9)

Active ingredient Purpose

Hydrocortisone 1%..................................................Anti-itch


Advanced Ingredient Data


Raw Label Data

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