Truelipids 1% Hydrocortisone Barrier Cream

Truelipids 1% Hydrocortisone Barrier Cream
SPL v4
SPL
SPL Set ID 037395dc-5b96-052e-e063-6394a90a26e4
Route
TOPICAL
Published
Effective Date 2023-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Medium-chain Triglycerides Tocopherol Polyglyceryl-2 Stearate Candelilla Wax Potassium Stearate Enoxolone Stearic Acid Glyceryl Monostearate C10-30 Cholesterol/lanosterol Esters Caprylyl Glycol Niacinamide Phytosphingosine Edetate Disodium Anhydrous Petrolatum Glycerin Glyceryl Distearate Xanthan Gum 1,2-hexanediol Ceramide Np Isostearyl Isostearate Water Neopentyl Glycol Diheptanoate Stearyl Alcohol Cetyl Alcohol Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-10

Description

Active Ingredient.........Purpose Hydrocortisone 1% .....Anti-itch


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

  • in the genital area if you have a vaginal discharge. consult a doctor
  • for the treatment of diaper rash. consult a doctor

when using this product

avoid contact with eyes

do not use more than directed unless told to do so by a doctor

do not put directly into rectim by using fingers or any mechanical device or applicator

Indications and Usage

Stop use and ask a doctor if

  • condition worsens
  • rectal bleeding occurs
  • symptoms persist 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 asked a doctor
Dosage and Administration

Directions

  • for itching of skin irritation, inflammation and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
    • children under 2 years of age: ask a doctor
    • for external anal and genital itching adult:
      • when practical clean the affected area with mild soap and water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissueor a soft cloth before applying
Description

Active Ingredient.........Purpose Hydrocortisone 1% .....Anti-itch

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol

Section 51945-4

CLMD

Sensitive Skin Care

True Lipids

1% Hydrocortisone Barrier Cream

Net Wt 1.7 fl oz (50g)

Section 55105-1

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • soaps
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 55106-9

Active Ingredient.........Purpose

Hydrocortisone 1% .....Anti-itch

Section 60561-8

Other information

store at 20°-25ºC (68º-77ºF)


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if

  • condition worsens
  • rectal bleeding occurs
  • symptoms persist 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 asked a doctor
Dosage and Administration (34068-7)

Directions

  • for itching of skin irritation, inflammation and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
    • children under 2 years of age: ask a doctor
    • for external anal and genital itching adult:
      • when practical clean the affected area with mild soap and water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissueor a soft cloth before applying
Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

  • in the genital area if you have a vaginal discharge. consult a doctor
  • for the treatment of diaper rash. consult a doctor

when using this product

avoid contact with eyes

do not use more than directed unless told to do so by a doctor

do not put directly into rectim by using fingers or any mechanical device or applicator

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 51727-6 (51727-6)

Inactive ingredients

Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol

Section 51945-4 (51945-4)

CLMD

Sensitive Skin Care

True Lipids

1% Hydrocortisone Barrier Cream

Net Wt 1.7 fl oz (50g)

Section 55105-1 (55105-1)

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • soaps
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 55106-9 (55106-9)

Active Ingredient.........Purpose

Hydrocortisone 1% .....Anti-itch

Section 60561-8 (60561-8)

Other information

store at 20°-25ºC (68º-77ºF)


Advanced Ingredient Data


Raw Label Data

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