Hydrocortisone Usp 1% Lotion

Hydrocortisone Usp 1% Lotion
SPL v7
SPL
SPL Set ID daad9a1e-98d2-4ce7-9d97-ac5d81905abb
Route
TOPICAL
Published
Effective Date 2024-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Water Glycerin Cetyl Alcohol Benzyl Alcohol Sodium Lauryl Sulfate Stearyl Alcohol Aloe Vera Leaf Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Hydrocortisone 1% (Micronized)

Purpose

Antipruritic (Anti-itch)


Medication Information

Purpose

Antipruritic (Anti-itch)

Description

Hydrocortisone 1% (Micronized)

Use

For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

  • insect bites
  • eczema
  • psoriasis
  • soaps
  • detergents
  • cosmetics,
  • jewelry,
  • poison oak,
  • poison sumac
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.
Section 42229-5

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Rev. 03/19

Manufactured in U.S.A

Section 51945-4

Warnings

For external use only.

Directions
  • Shake will before using.
  • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
  • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.
Questions?

Please Call 1(877) 225-6999

Active Ingredient

Hydrocortisone 1% (Micronized)

Other Information

• Store away from excessive heat or cold.  Shake well before using.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

When Using This Product

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If
  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • Do no use for diaper rash. Consult a doctor.
Keep Out of Reach of Children

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


Structured Label Content

Use

For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

  • insect bites
  • eczema
  • psoriasis
  • soaps
  • detergents
  • cosmetics,
  • jewelry,
  • poison oak,
  • poison sumac
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.
Section 42229-5 (42229-5)

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Rev. 03/19

Manufactured in U.S.A

Section 51945-4 (51945-4)

Purpose

Antipruritic (Anti-itch)

Warnings

For external use only.

Directions
  • Shake will before using.
  • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
  • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.
Questions?

Please Call 1(877) 225-6999

Active Ingredient

Hydrocortisone 1% (Micronized)

Other Information

• Store away from excessive heat or cold.  Shake well before using.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

When Using This Product (When using this product)

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • Do no use for diaper rash. Consult a doctor.
Keep Out of Reach of Children (Keep out of Reach of Children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)