FDA Label for Afassco 1% Hydrocortisone
View Indications, Usage & Precautions
Afassco 1% Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Afassco Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
res
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