Clinicalm ®

Clinicalm ®
SPL v6
SPL
SPL Set ID febcf7e8-668c-a5c9-e053-6394a90aec39
Route
TOPICAL
Published
Effective Date 2023-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Hyaluronate Sodium Lecithin, Soybean Aloe Vera Leaf 1,2-hexanediol 4-tert-butylcyclohexanol Alcohol Asiaticoside Oatmeal Levomenol Butylene Glycol Medium-chain Triglycerides Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Ceramide Np Cetearyl Olivate Glycerin Honey Hyaluronic Acid Hydroxyphenyl Propamidobenzoic Acid Linseed Oil Lysine Hydrochloride Olive Oil Pentylene Glycol Phenoxyethanol Sodium Hydroxide Sorbic Acid Sorbitan Olivate Soy Sphingolipids Squalane Tocopherol Trisodium Ethylenediamine Disuccinate Tropolone Water Xanthan Gum Yeast .beta.-d-glucan Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Drug Facts

Purpose

Antipruritic (anti-itch)


Medication Information

Purpose

Antipruritic (anti-itch)

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

Do not use for the treatment of diaper rash. Consult a physician.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only

Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a physician.

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 physician.

Active Ingredient

Hydrocortisone (1%)

Other Information

Store at 15°–25°C (59°–77°F).

Inactive Ingredients

Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Alcohol Denat., Cetearyl Olivate, Squalane, Olea Europaea (Olive) Fruit Oil, Sorbitan Olivate, Caprylyl Glycol, Phenoxyethanol, Pentylene Glycol, Linum Usitatissimum (Linseed) Seed Oil, Xanthan Gum, 4-t-Butylcyclohexanol, 1,2-Hexanediol, Honey/Mel/Miel, Carbomer, Phospholipids, Asiaticoside, Beta-Glucan, Bisabolol, Lysine HCl, Sodium Hydroxide, Aloe Barbadensis Leaf Juice Powder, Ceramide NP, Sorbic Acid, Trisodium Ethylenediamine Disuccinate, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Hyaluronic Acid, Sphingolipids, Tocopherol, Tropolone, Hydroxyphenyl Propamidobenzoic Acid.

Questions Or Comments?

877.722.7546

Principal Display Panel 60 G Tube Box

PCA skin ®

CliniCalm ®1%

2.1 oz/60g


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

Do not use for the treatment of diaper rash. Consult a physician.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antipruritic (anti-itch)

Warnings

For external use only

Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a physician.

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 physician.

Active Ingredient (Active ingredient)

Hydrocortisone (1%)

Other Information (Other information)

Store at 15°–25°C (59°–77°F).

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Alcohol Denat., Cetearyl Olivate, Squalane, Olea Europaea (Olive) Fruit Oil, Sorbitan Olivate, Caprylyl Glycol, Phenoxyethanol, Pentylene Glycol, Linum Usitatissimum (Linseed) Seed Oil, Xanthan Gum, 4-t-Butylcyclohexanol, 1,2-Hexanediol, Honey/Mel/Miel, Carbomer, Phospholipids, Asiaticoside, Beta-Glucan, Bisabolol, Lysine HCl, Sodium Hydroxide, Aloe Barbadensis Leaf Juice Powder, Ceramide NP, Sorbic Acid, Trisodium Ethylenediamine Disuccinate, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Hyaluronic Acid, Sphingolipids, Tocopherol, Tropolone, Hydroxyphenyl Propamidobenzoic Acid.

Questions Or Comments? (Questions or comments?)

877.722.7546

Principal Display Panel 60 G Tube Box (PRINCIPAL DISPLAY PANEL - 60 g Tube Box)

PCA skin ®

CliniCalm ®1%

2.1 oz/60g


Advanced Ingredient Data


Raw Label Data

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