SPL v1
SPL
SPL Set ID 302d4327-354b-a252-e063-6394a90a20b6
Route
TOPICAL
Published
Effective Date 2025-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 mg)
Inactive Ingredients
Cetearyl Alcohol Phenoxyethanol Coconut Alcohol Glucose Aloe Barbadensis Leaf Juice Sodium Polyacrylate (8000 Mw) Water Maltodextrin Lauryl Glucoside Peg-100 Stearate Butyrospermum Parkii (shea) Butter Ethylhexyl Palmitate Dimethicone Myristyl Myristate Colloidal Silver Sclerocarya Birrea Seed Oil Ginger Allantoin Panthenol Caprylic/capric Triglyceride .alpha.-tocopherol Acetate, Dl- Glyceryl Stearate Pentylene Glycol 4-t-butylcyclohexanol Glycerin Bisabolol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-19

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps and detergents, cosmetics, jewelry.

Warnigs

For external use only. Avoid contact with eyes. 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 use this or any other hydrocortisone product unless you have consulted a doctor.

Directions

Adults and children 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, consult a doctor.

Other Information

Store at 20°C (66° – 77°F)

Active Ingredients

Hydrocortisone 1%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Butyrospermum Parkii (Shea) Butter, Dimethicone, Lauryl Glucoside, Myristyl Myristate, 4-t-Butylcyclohexanol, Phenoxyethanol, Coconut Alcohol, Sodium Polyacrylate, Colloidal Silver, Sclerocarya Birrea Seed Oil, Allantoin, Panthenol, Tocopheryl Acetate, Bisabolol, Ethylhexylglycerin, Maltodextrin, Glucose, Zingiber Officinale (Ginger) Root Extract, Aloe Barbadensis Leaf Juice

Keep Out of Reach of Children.

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

Vitality Post Treatment Repair Cream 2 Fl. Oz.


Structured Label Content

Uses (USES)

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps and detergents, cosmetics, jewelry.

Purpose (PURPOSE)

Anti-itch

Warnigs (WARNIGS)

For external use only. Avoid contact with eyes. 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 use this or any other hydrocortisone product unless you have consulted a doctor.

Directions (DIRECTIONS)

Adults and children 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, consult a doctor.

Other Information (OTHER INFORMATION)

Store at 20°C (66° – 77°F)

Active Ingredients (ACTIVE INGREDIENTS)

Hydrocortisone 1%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Butyrospermum Parkii (Shea) Butter, Dimethicone, Lauryl Glucoside, Myristyl Myristate, 4-t-Butylcyclohexanol, Phenoxyethanol, Coconut Alcohol, Sodium Polyacrylate, Colloidal Silver, Sclerocarya Birrea Seed Oil, Allantoin, Panthenol, Tocopheryl Acetate, Bisabolol, Ethylhexylglycerin, Maltodextrin, Glucose, Zingiber Officinale (Ginger) Root Extract, Aloe Barbadensis Leaf Juice

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

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

Vitality Post Treatment Repair Cream 2 Fl. Oz. (Vitality Post-Treatment Repair Cream 2 fl. oz.)


Advanced Ingredient Data


Raw Label Data

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