FDA Label for Welly Itch Fix
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- ADULTS AND CHILDREN 2 YEARS AND OLDER
- CHILDREN UNDER 2 YEARS OF AGE
- FOR EXTERNAL ANAL ITCHING:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL – CAN LABEL
- PRINCIPAL DISPLAY PANEL – 0.57OZ TUBE LABEL
Welly Itch Fix Product Label
The following document was submitted to the FDA by the labeler of this product Welly Health Pbc. 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
Active Ingredient
Hydrocortisone 1.0%
Purpose
Anti-itch
Uses
For temporary 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
- psoriasis
- external feminine, genital and anal itching.
Other uses of this product should be only under the advice and supervision of a doctor.
Warnings
For external use only
Do Not Use
- for the treatment of diaper rash, consult a doctor.
- for external genital itching if you have a vaginal discharge, consult a doctor.
When Using This Product
- avoid contact with eyes
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use And Ask A Doctor If
- If condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Adults And Children 2 Years 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.
For External Anal Itching:
- adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- children under 12 years of age with external anal itching: consult a doctor.
Other Information
store at controlled room temperature 68° - 77°F (20°-25°C).
Inactive Ingredients
Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water
Principal Display Panel – Can Label
Welly First Aid Itch Fix
NDC 72663-155-50
Hydrocortisone 1% Anti-itch Cream
2 tubes -0.57 oz(16g) Total Net Wt 1.14oz (32g)
Principal Display Panel – 0.57Oz Tube Label
NDC 72663-155-50 Welly First Aid Itch fix
Hydrocortisone 1% Anti-itch Cream Net Wt. 0.57 oz (16g)
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