Maximum Strength Hydrocortisone 1%

Maximum Strength Hydrocortisone 1%
SPL v6
SPL
SPL Set ID caf50f12-f35c-4e9e-8ef7-3b0c84e225ee
Route
TOPICAL
Published
Effective Date 2019-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-22

Description

Drug Facts

Purpose

Antipruritic (Anti-itch)


Medication Information

Purpose

Antipruritic (Anti-itch)

Description

Drug Facts

Uses
  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF THE 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 if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • rectal bleeding occurs
Section 50567-7

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into rectum by using fingers or any mechanical device or applicator
Section 50570-1

Do not use

  • for the treatment of diaper rash. Consult a doctor.
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
Warnings

For external use only

Questions

1-800-858-3889

Active Ingredient

Hydrocortisone, USP 1%

Other Information
  • store at room temperature
Inactive Ingredients

mineral oil, petrolatum

Principal Display Panel 28 G Tube Box

De La Cruz ®

Anti-Itch



Ointment

Maximum Strength

Hydrocortisone 1%

For Relief of Itching, Rashes



and Skin Irritations

  • Fragrance Free
  • Rapid Relief

Net Wt. 1 OZ (28g)


Structured Label Content

Uses
  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF THE 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 if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • rectal bleeding occurs
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into rectum by using fingers or any mechanical device or applicator
Section 50570-1 (50570-1)

Do not use

  • for the treatment of diaper rash. Consult a doctor.
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
Purpose

Antipruritic (Anti-itch)

Warnings

For external use only

Questions

1-800-858-3889

Active Ingredient (Active ingredient)

Hydrocortisone, USP 1%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

mineral oil, petrolatum

Principal Display Panel 28 G Tube Box (PRINCIPAL DISPLAY PANEL - 28 g Tube Box)

De La Cruz ®

Anti-Itch



Ointment

Maximum Strength

Hydrocortisone 1%

For Relief of Itching, Rashes



and Skin Irritations

  • Fragrance Free
  • Rapid Relief

Net Wt. 1 OZ (28g)


Advanced Ingredient Data


Raw Label Data

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