Active Ingredient(S)
1% Clotrimazole
Velloryn 1% Clotrimazole Antifungal Cream
FDA Label NDC 84558-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product Velloryn 1% Clotrimazole Antifungal (NDC 84558-017). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
. relieves itching, burning, cracking, and scaling associated with
athlete's foot, jock itch, and ringworm
. helps relieve symptoms associated with athlete's foot, jock itch, and
ringworm
Warnings
For external use only
Do Not Use
.on children under 2 years of age unless directed by a doctor.
Otc - When Using
avoid contact with the eyes
Otc - Stop Use
. irritation occurs
. there is no improvement within 4 weeks (for athlete's foot & ringworm) or within 2 weeks (for jock itch)
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 at 1-800-222-1222.
Directions
· adults and children 2 years and older: apply a thin layer to the
affected area 2-3 times daily
.children under 2 years: do not use; ask a doctor
Other Information
Do not use if seal is broken. Store at 15°C-30°C (59°F-86°F).
See carton for directions.
Inactive Ingredients
Water, Propylene Glycol, Glycerin, Ethylhexy| Palmitate,Cetyl
Alcohol, Glycery| Stearate, Sorbitan Stearate, Polysorbate 20,
Acrylates/C10-30 Alky| Acrylate Crosspolymer, Triethanolamine,
Phenoxyethanol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice,
Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia
(Tea Tree) Oil, Thymus Vulgaris(Thyme) Extract, Tocopheryl
Acetate
Package Label - Principal Display Panel
Undefined (Label)
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