Immediate Comfort

Immediate Comfort
SPL v2
SPL
SPL Set ID 4c561849-e91b-4790-b6e7-8222e22df5f9
Route
TOPICAL
Published
Effective Date 2012-08-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.088 mL)
Inactive Ingredients
Butylene Glycol Alkyl (c12-15) Benzoate Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Glyceryl Monostearate Sunflower Oil Methylisothiazolinone Peg-100 Stearate Phenoxyethanol Polysorbate 80 Sodium Hydroxide Sorbitol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-23

Description

Active Ingredient Purpose Hydrocortisone Acetate 1% Anti-itch lotion


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product avoid contact with the eyes.

Indications and Usage

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Dosage and Administration

Directions

Apply to affected area no more than 3 to 4 times daily.

Description

Active Ingredient Purpose Hydrocortisone Acetate 1% Anti-itch lotion

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

Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)

Section 51945-4

Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.

Section 55105-1

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to exzema, detergents, cosmetics, jewelry, dermatitis, psoriasis.

Other uses of this product should be only under the advice and supervision of a doctor.

Section 55106-9

Active Ingredient Purpose

Hydrocortisone Acetate 1% Anti-itch lotion


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Dosage and Administration (34068-7)

Directions

Apply to affected area no more than 3 to 4 times daily.

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product avoid contact with the 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.

Section 51727-6 (51727-6)

Inactive ingredients

Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)

Section 51945-4 (51945-4)

Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.

Section 55105-1 (55105-1)

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to exzema, detergents, cosmetics, jewelry, dermatitis, psoriasis.

Other uses of this product should be only under the advice and supervision of a doctor.

Section 55106-9 (55106-9)

Active Ingredient Purpose

Hydrocortisone Acetate 1% Anti-itch lotion


Advanced Ingredient Data


Raw Label Data

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