Genuine Hydrocortisone Cream Maximum Strength Anti-itch

Genuine Hydrocortisone Cream Maximum Strength Anti-itch
SPL v14
SPL
SPL Set ID 555ae674-f1fa-4334-81c0-0085cdff1b9a
Route
TOPICAL
Published
Effective Date 2011-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-23

Description

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Maximum strength Anti-itch


Medication Information

Purpose

Maximum strength Anti-itch

Description

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Uses

For temporary relief of itching associated with minor skin irritations and rashes due to eczema, seborrheic dermatitis, insect bites, poison ivy, poison oak, poison sumac, sores, detergents, cosmetic and jewelry. Other uses of this product should be only under supervision of a physician.

Section 51945-4


Genuine Hydrocortisone Cream



Maximum Strength



Anti-Itch



Net Wt 0.9g (1/32 oz)



Manufactured in CHINA for

Genuine First Aid

Warnings

 For external use only.

Directions

Adults and Children 2 years and older apply to affected area no more than 4 times daily,

Children under 2: Consult a doctor

Do Not Use:

In eyes. On children under 2 years of age, unless under advice and supervision of a doctor.

If condition persists for more than 7 days.

Product Labeling

Active Ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Other Information

Store at room temperature

(Do not freeze)

Inactive Ingredients

Propylene glycol, Carbomer, Purified water.

Keep Out of Reach of Children

If ingested, get medical help or contact a Poison Control Center immediately.




Structured Label Content

Uses

For temporary relief of itching associated with minor skin irritations and rashes due to eczema, seborrheic dermatitis, insect bites, poison ivy, poison oak, poison sumac, sores, detergents, cosmetic and jewelry. Other uses of this product should be only under supervision of a physician.

Section 51945-4 (51945-4)


Genuine Hydrocortisone Cream



Maximum Strength



Anti-Itch



Net Wt 0.9g (1/32 oz)



Manufactured in CHINA for

Genuine First Aid

Purpose

Maximum strength Anti-itch

Warnings

 For external use only.

Directions

Adults and Children 2 years and older apply to affected area no more than 4 times daily,

Children under 2: Consult a doctor

Do Not Use: (Do not use:)

In eyes. On children under 2 years of age, unless under advice and supervision of a doctor.

If condition persists for more than 7 days.

Product Labeling

Active Ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Other Information

Store at room temperature

(Do not freeze)

Inactive Ingredients

Propylene glycol, Carbomer, Purified water.

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

If ingested, get medical help or contact a Poison Control Center immediately.




Advanced Ingredient Data


Raw Label Data

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