Dermacort Anti-itch Cream Content Of Label

Dermacort Anti-itch Cream Content Of Label
SPL v1
SPL
SPL Set ID a0962a88-8a49-414c-aecf-db94ec033f16
Route
TOPICAL
Published
Effective Date 2011-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL 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 jewelry
  • other uses 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, ask a doctor.

Description

Active ingredient Hydrocortisone 1%

Section 44425-7

Other information do not store above 100°F (38°C)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use for the treatment of diaper rash. Ask 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, steareth-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 jewelry
  • other uses 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, ask 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 (38°C)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

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. Ask 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, steareth-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

All Sections (JSON)