Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID aa47ff08-07b3-4fd1-bae5-420e4b928f06
Route
TOPICAL
Published
Effective Date 2017-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Glycerin Water Caprylic/capric Acid Rosa Canina Fruit Oil Squalane Sorbitan Olivate .alpha.-bisabolol, (+)- Carbomer 940 Gluconolactone Lonicera Caprifolium Flower Hedychium Coronarium Root Lonicera Japonica Flower Sodium Benzoate Potassium Sorbate Caprylyl Glycol Tocopherol Soybean Oil Aloe Vera Whole Sodium Hydride Xanthan Gum Trisodium Ethylenediamine Disuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-31

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to:
  • dermatitis, exzema, insect bites
  • other uses of this prouct should be only under the advice and supervision of a doctor
Warnings

For external use only

Do not use

  • for the treatment of iaper rash. Ask a doctor

When using this product

• avoid contact with the eyes

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

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 hyrdrocortisone product unless you have asked a doctor
Directions
  • for itching of skin irritation, inflamation and rashes
  • adults an chilren 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
Active Ingredients

Hydrocortisone 1%

Inactive Ingredients

Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Rosa Canina (Rose Hip) Fruit Oil, Squalane, Sorbitan Olivate, Bisabolol, Carbomer, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Hedychium Coronarium (White Ginger) Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Sodium Benzoate, Phenethyl Alcohol, Potassium Sorbate, Caprylyl Glycol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice Powder, Phytic Acid, Sodium Hydroxide, Xanthan Gum, Trisodium Ethylenediamine Disuccinate

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.


Structured Label Content

Uses
  • temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to:
  • dermatitis, exzema, insect bites
  • other uses of this prouct should be only under the advice and supervision of a doctor
Purpose

Anti-itch

Warnings

For external use only

Do not use

  • for the treatment of iaper rash. Ask a doctor

When using this product

• avoid contact with the eyes

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

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 hyrdrocortisone product unless you have asked a doctor
Directions
  • for itching of skin irritation, inflamation and rashes
  • adults an chilren 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
Active Ingredients

Hydrocortisone 1%

Inactive Ingredients

Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Rosa Canina (Rose Hip) Fruit Oil, Squalane, Sorbitan Olivate, Bisabolol, Carbomer, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Hedychium Coronarium (White Ginger) Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Sodium Benzoate, Phenethyl Alcohol, Potassium Sorbate, Caprylyl Glycol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice Powder, Phytic Acid, Sodium Hydroxide, Xanthan Gum, Trisodium Ethylenediamine Disuccinate

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)