Genuine Hydrocortisone Cream

Genuine Hydrocortisone Cream
SPL v1
SPL
SPL Set ID 597cf1be-50e3-4cdf-b013-1eb72fea667d
Route
TOPICAL
Published
Effective Date 2011-03-29
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 NOT FINAL Active Since 2011-03-29

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 42229-5

GFA Production Xiamen Co., Ltd

No. 20 Huli Industrial Park, Meixi Road,

Tong'an, Xiamen, Fujian, China 361100

Wellkang Ltd t/a Wellkang Tech Consulting

Suite B, 29 Harley Street

LONDON W1G 9QR, England, United Kingdom

Copyright (c) 2010 GFA Production Xiamen Co., Ltd

All rights reserved



Section 51945-4

Genuine Hydrocortisone Cream

Maximum Strength

Anti Itch





Active ingredient:

Hydrocortisone Acetate

(equivalent to Hydrocortisone 1%)



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.

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 42229-5 (42229-5)

GFA Production Xiamen Co., Ltd

No. 20 Huli Industrial Park, Meixi Road,

Tong'an, Xiamen, Fujian, China 361100

Wellkang Ltd t/a Wellkang Tech Consulting

Suite B, 29 Harley Street

LONDON W1G 9QR, England, United Kingdom

Copyright (c) 2010 GFA Production Xiamen Co., Ltd

All rights reserved



Section 51945-4 (51945-4)

Genuine Hydrocortisone Cream

Maximum Strength

Anti Itch





Active ingredient:

Hydrocortisone Acetate

(equivalent to Hydrocortisone 1%)



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.

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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