Afassco 1% Hydrocortisone
FDA Label NDC 51532-4608

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Afassco 1% Hydrocortisone (NDC 51532-4608). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Hydrocorticone Cream 1%

Otc - Active Ingredient

Active Ingredients (In Each Gram)

Hydrocortisone 1%

Otc - Purpose

Purpose 

Anti-itch

Indications & 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

Warnings

Warnings

  • for external use only

Otc - Ask Doctor

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

Otc - When Using

When using this product:

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

Otc - Do Not Use

Do not use:

  • with any other Hydrocortisone product unless you have consulted a doctor

Otc - Keep Out Of Reach Of Children

  • KEEP OUT OF REACH OF CHILDREN.  If swallowed contact a Poison Control center right away.

Dosage & 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

Other Safety Information

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

Inactive Ingredient

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin,

Ceteareth-20, Isopropyl Myristate,

EDTA-2NA, Phenoxyethanol,

Tocopheryl Acetate,

Aloe Barbadensis Leaf Juice

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

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