1% Hydrocortisone Cream

1% Hydrocortisone Cream
SPL v5
SPL
SPL Set ID 9b8606c7-99f8-4019-b173-d4ab2e9d2d1a
Route
TOPICAL
Published
Effective Date 2023-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Water Cetostearyl Alcohol Glycerin Polyoxyl 20 Cetostearyl Ether Isopropyl Myristate Edetate Disodium Phenoxyethanol .alpha.-tocopherol Acetate, D- Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-12-07

Description

Drug Facts Hydrocorticone Cream 1%


Medication Information

Warnings and Precautions

Warnings

  • for external use only
Indications and Usage

Uses:

  • for the temporary temporarily relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis scrapes
  • for external genital, feminine, and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration

Directions

• For 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

• Adults for external anal itching when practical, cleanse the area with mild soap and warm water and rinse thoroughly or by patting or blotting     with an appropriate cleansing pad

• Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product

• Children under 12 years of age; for external itching, consult a doctor

Description

Drug Facts Hydrocorticone Cream 1%

Section 42229-5

Drug Facts

Hydrocorticone Cream 1%

Section 50565-1
  • KEEP OUT OF REACH OF CHILDREN.  If swallowed contact a Poison Control center right away.
Section 50567-7

When using this product:

  • avoid contacty with eyes
  • do not put this produce into rectum by using fingers or any mechanical device or applicator

Section 50569-3

Consult a doctor:

  • before use if you have a vaginal discharge (for external feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again in a few days
  • ask a doctor before use if you are using any other hydrocortisone product
Section 50570-1

Do not use:

  • with any other Hydrocortisone product unless you have consulted a doctor
Section 51727-6

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin,

Ceteareth-20, Isopropyl Myristate,

EDTA-2NA, Phenoxyethanol,

Tocopheryl Acetate,

Aloe Barbadensis Leaf Juice

Section 55105-1

Purpose 

Anti-itch

Section 55106-9

Active Ingredients (In Each Gram)

Hydrocortisone 1%

Section 60561-8

Other Information:

  • Store at controlled room temperature 15° to 30° C (59° to 86° F)
  • Tamper evident.  Do not use if packet is torn, cut, or opened.
  • Avoid excessive heat and humidity
Principal Display Panel

Afassco¦ ¦®

The First Choice

in First Aid

MAXIMUM STRENGTH

HYDROCORTISONE

PLUS MOISTURIZING ALOE

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                                25 ct.

Afassco¦ ¦®

The First Choice in First Aid

REMOVE TOP FOR EASY ACCESS

Compare To

Hydrocortisone

MAXIMUM STRENGTH

HYDROCORTISONE

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                    25 ct.

Afassco¦ ¦®

The First Choice in First Aid

MAXIMUM STRENGTH

HYDROCORTISONE

1% Crema de Fydrocortisona

instructiones: Para Adultos y ninos

2 anos y mas viejo.  Los ninos bajo

2 anos, consultan un medico para

picar anal externo.  Limpia el areaa

afectada con jabon y aclarado

aplique el producto.

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                      25 ct.

Afassco¦ ¦®

The First Choice in First Aid

Manufactured for Afassco, Inc. Minden, NV 89423

6   70254   60812   5

↓25 ct. Box↓

↓6 ct. Box↓

↓Unit Dose Package Label↓

Afassco¦ ¦®

The First Choice in First Aid

1% Hydrocortisone

Cream

Manufactured for Afassco

Minden, NV 89423

1gm (1/32 oz)

 Made in China

res


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • for the temporary temporarily relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis scrapes
  • for external genital, feminine, and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration (34068-7)

Directions

• For 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

• Adults for external anal itching when practical, cleanse the area with mild soap and warm water and rinse thoroughly or by patting or blotting     with an appropriate cleansing pad

• Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product

• Children under 12 years of age; for external itching, consult a doctor

Warnings and Precautions (34071-1)

Warnings

  • for external use only
Section 42229-5 (42229-5)

Drug Facts

Hydrocorticone Cream 1%

Section 50565-1 (50565-1)
  • KEEP OUT OF REACH OF CHILDREN.  If swallowed contact a Poison Control center right away.
Section 50567-7 (50567-7)

When using this product:

  • avoid contacty with eyes
  • do not put this produce into rectum by using fingers or any mechanical device or applicator

Section 50569-3 (50569-3)

Consult a doctor:

  • before use if you have a vaginal discharge (for external feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again in a few days
  • ask a doctor before use if you are using any other hydrocortisone product
Section 50570-1 (50570-1)

Do not use:

  • with any other Hydrocortisone product unless you have consulted a doctor
Section 51727-6 (51727-6)

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin,

Ceteareth-20, Isopropyl Myristate,

EDTA-2NA, Phenoxyethanol,

Tocopheryl Acetate,

Aloe Barbadensis Leaf Juice

Section 55105-1 (55105-1)

Purpose 

Anti-itch

Section 55106-9 (55106-9)

Active Ingredients (In Each Gram)

Hydrocortisone 1%

Section 60561-8 (60561-8)

Other Information:

  • Store at controlled room temperature 15° to 30° C (59° to 86° F)
  • Tamper evident.  Do not use if packet is torn, cut, or opened.
  • Avoid excessive heat and humidity
Principal Display Panel

Afassco¦ ¦®

The First Choice

in First Aid

MAXIMUM STRENGTH

HYDROCORTISONE

PLUS MOISTURIZING ALOE

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                                25 ct.

Afassco¦ ¦®

The First Choice in First Aid

REMOVE TOP FOR EASY ACCESS

Compare To

Hydrocortisone

MAXIMUM STRENGTH

HYDROCORTISONE

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                    25 ct.

Afassco¦ ¦®

The First Choice in First Aid

MAXIMUM STRENGTH

HYDROCORTISONE

1% Crema de Fydrocortisona

instructiones: Para Adultos y ninos

2 anos y mas viejo.  Los ninos bajo

2 anos, consultan un medico para

picar anal externo.  Limpia el areaa

afectada con jabon y aclarado

aplique el producto.

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                      25 ct.

Afassco¦ ¦®

The First Choice in First Aid

Manufactured for Afassco, Inc. Minden, NV 89423

6   70254   60812   5

↓25 ct. Box↓

↓6 ct. Box↓

↓Unit Dose Package Label↓

Afassco¦ ¦®

The First Choice in First Aid

1% Hydrocortisone

Cream

Manufactured for Afassco

Minden, NV 89423

1gm (1/32 oz)

 Made in China

res


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