Dermacort

Dermacort
SPL v6
SPL
SPL Set ID 24044b0f-dd1e-4762-82b8-7a28b08c2f77
Route
TOPICAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Polyoxyl 100 Stearate Propylparaben Steareth-2 Steareth-21 Tea Tree Oil Trolamine Water Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Cyclomethicone 5 Dimethicone Glycerin Glyceryl Monostearate Isopropyl Palmitate Methylparaben Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-08-02

Description

Active ingredient Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

  • For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, psoriasis, , seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelery
  • Other use of this product should be only under the advice and supervision of a doctor.

Dosage and Administration

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.

Description

Active ingredient Hydrocortisone 1%

Section 44425-7

Other information Do not store above 100°F.

Section 50565-1

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Section 50567-7

When using this product avoid contact with the eyes.

Section 50570-1

Do not use for the treatment of diaper rash. Consult a doctor.

Section 51727-6

Inactive ingredients Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Cetyl Alcohol, Cyclopentasiloxane, Deionized Water, Dimethicone, Glycerin USP, Glyceryl Stearate and PEG-100 Stearate, Isopropyl Palmitate, Melaleuca Oil, Methylparaben, Petrolatum USP, Propylparaben, Serareth-2, Steareth-21, Triethanolamine.

Section 51945-4

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active ingredient

Hydrocortisone 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, psoriasis, , seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelery
  • Other use of this product should be only under the advice and supervision of a doctor.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 44425-7 (44425-7)

Other information Do not store above 100°F.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.

Section 50570-1 (50570-1)

Do not use for the treatment of diaper rash. Consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Cetyl Alcohol, Cyclopentasiloxane, Deionized Water, Dimethicone, Glycerin USP, Glyceryl Stearate and PEG-100 Stearate, Isopropyl Palmitate, Melaleuca Oil, Methylparaben, Petrolatum USP, Propylparaben, Serareth-2, Steareth-21, Triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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