Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 5bcdd479-b645-4209-9413-643dfa405c0f
Route
TOPICAL
Published
Effective Date 2011-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (.01 mg)
Inactive Ingredients
Water Glycerin Medium-chain Triglycerides Cetearyl Olivate Hedychium Coronarium Root Levomenol Rosa Canina Fruit Oil Squalane Tocopherol Aloe Vera Leaf Lonicera Caprifolium Flower Lonicera Japonica Flower Soybean Oil Sorbitan Olivate Xanthan Gum Phytic Acid Carbomer 934 Potassium Sorbate Sodium Hydroxide Gluconolactone Sodium Benzoate Caprylyl Glycol Phenylethyl Alcohol Trisodium Ethylenediamine Disuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-06-02
Description

Active Ingredient(s):  Hydrocortisone 1%

Medication Information

Warnings and Precautions

Warnings:  For external use only.  Avoid contact with eyes.

Indications and Usage

Use:  For temporary relief of itching and discomfort associated with minor skin irritations, inflammation and rashes.

Dosage and Administration

Directions:  Adults and children 12 years of age or older:  Apply to the affected area no more than 3 to 4 times daily.

Description

Active Ingredient(s):  Hydrocortisone 1%

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.  Children under 12 years of age:  do not use, consult a physician.

Section 51727-6
Inactive Ingredients:  Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Hedychium Coronarium (White Giner) Root Extract, Bisabolol (L-alpha), Rosa Canina (Rose Hip) Fruit Oil, Squalane, Tocopherol (D-alpha), Aloe Barbadensis Leaf Juice Powder, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Glycine Soja (Soybean) Oil, Sorbitan Olivate, Xanthan Gum, Phytic Acid, Carbomer, Potassium Sorbate, Sodium Hydroxide, Calcium Gluconate, Gluconolactone, Sodium Benzoate, Caprylyl Glycol, Phenethyl Alcohol, Trisodium Ethylenediamine Disuccinate

Section 51945-4

Prinicpal Display Panel

Section 55105-1

Purpose:  For itchy skin.

Section 55106-9

Active Ingredient(s):  Hydrocortisone 1%

Structured Label Content

Indications and Usage (34067-9)

Use:  For temporary relief of itching and discomfort associated with minor skin irritations, inflammation and rashes.

Dosage and Administration (34068-7)

Directions:  Adults and children 12 years of age or older:  Apply to the affected area no more than 3 to 4 times daily.

Warnings and Precautions (34071-1)

Warnings:  For external use only.  Avoid contact with eyes.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.  Children under 12 years of age:  do not use, consult a physician.

Section 51727-6 (51727-6)
Inactive Ingredients:  Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Hedychium Coronarium (White Giner) Root Extract, Bisabolol (L-alpha), Rosa Canina (Rose Hip) Fruit Oil, Squalane, Tocopherol (D-alpha), Aloe Barbadensis Leaf Juice Powder, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Glycine Soja (Soybean) Oil, Sorbitan Olivate, Xanthan Gum, Phytic Acid, Carbomer, Potassium Sorbate, Sodium Hydroxide, Calcium Gluconate, Gluconolactone, Sodium Benzoate, Caprylyl Glycol, Phenethyl Alcohol, Trisodium Ethylenediamine Disuccinate

Section 51945-4 (51945-4)

Prinicpal Display Panel

Section 55105-1 (55105-1)

Purpose:  For itchy skin.

Section 55106-9 (55106-9)

Active Ingredient(s):  Hydrocortisone 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.499925 · Updated: 2026-03-14T22:52:49.153069