FDA Label for Quadrydern
View Indications, Usage & Precautions
Quadrydern Product Label
The following document was submitted to the FDA by the labeler of this product Productos Zapotol Corp. 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.
Otc - Active Ingredient
Active ingredient Purpose
Hydrocortisone 1%..................................................................Anti-itch
Otc - Purpose
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison ivy, oak, sumac
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advice and supervision of a doctor
Warnings
Warnings For external use only
Otc - Do Not Use
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
- more than directed unless directed by a doctor.
Otc - When Using
When using this product
- avoid contact with the eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor
- rectal bleeding occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- for itching of skin irritation, inflammation, and rashes:
- 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: ask a doctor
- Adults: for external anal itching:
- for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Storage And Handling
Other information
- Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredient
Inactive ingredients aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax
Dosage & Administration
Distributed By:
Productos Zapotol Corp.
Palmdale, CA 93550
Made in China
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