Thompson Hydrocortisone Cream 1%

Thompson Hydrocortisone Cream 1%
SPL v4
SPL
SPL Set ID f8740314-7e1f-815e-e053-6294a90a6eae
Route
TOPICAL
Published
Effective Date 2023-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Methylparaben Propylparaben Mineral Oil Paraffin Petrolatum Water White Wax Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glycerin Phenoxyethanol Glyceryl Monostearate Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01

Description

Drug Facts


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 and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewlry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration

Directions

  • for adults and children 2 years of age and older: apply to the affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Description

Drug Facts

Section 42229-5

Drug Facts

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 or lasts more than 7 days, or clears and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs
Section 50570-1

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6

Inactive ingredients

cetearyl alcohol*, ceteareth-20*, emulsifying wax*, ethanol*, ethylhexylglycerin*, glycerin*, glyceryl fatty acid ester*, methylpharaben*, mineral oil, paraffin*, petrolatum, phenoxyethanol*, propylparaben*, purified water, water*, white wax*

*may contain

Section 51945-4

Pull up and tear off to dispense

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated with

Minor Skin Irritation and Rashes

Product CS93373 0.9 g (1/32 oz) Packets

25/Box

THOMPSON

Safety Works | Business Thrives™

Section 53413-1

Questions or comments? 877.506.4291

Section 55105-1

Purose

Anti-itch

Section 55106-9

Active ingredient

Hydrocortisone 1%

Section 60561-8

Other information

  • store at room temperature (do not freeze)
  • tamper evident. do not use any opened or torn packets

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewlry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration (34068-7)

Directions

  • for adults and children 2 years of age and older: apply to the affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

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 or lasts more than 7 days, or clears and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs
Section 50570-1 (50570-1)

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6 (51727-6)

Inactive ingredients

cetearyl alcohol*, ceteareth-20*, emulsifying wax*, ethanol*, ethylhexylglycerin*, glycerin*, glyceryl fatty acid ester*, methylpharaben*, mineral oil, paraffin*, petrolatum, phenoxyethanol*, propylparaben*, purified water, water*, white wax*

*may contain

Section 51945-4 (51945-4)

Pull up and tear off to dispense

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated with

Minor Skin Irritation and Rashes

Product CS93373 0.9 g (1/32 oz) Packets

25/Box

THOMPSON

Safety Works | Business Thrives™

Section 53413-1 (53413-1)

Questions or comments? 877.506.4291

Section 55105-1 (55105-1)

Purose

Anti-itch

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone 1%

Section 60561-8 (60561-8)

Other information

  • store at room temperature (do not freeze)
  • tamper evident. do not use any opened or torn packets

Advanced Ingredient Data


Raw Label Data

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