Otc - Active Ingredient
Clotrimazole USP 1%
Purpose Antifungal
Putrizen Antifungal Cream
FDA Label NDC 85593-162
7 label sections · Submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Putrizen Antifungal (NDC 85593-162). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Proven effective in the treatment of most athlete's foot (tinea pedis)
· Helps prevent most athlete's foot with daily use.
For effective relief of itching, burning and cracking.
Otc - Keep Out Of Reach Of Children
Keep out ofreach of children.
If swallowed, get medical help or contact a Poison Control Center
right away.
Warnings
Wamings:
For extemaluse only.
Donotuse
· on children under 2 years of age unless directed by a doctor.
Dosage & Administration
·wash the affected area and dry thoroughly.
·apply a thin layer of the product over the affected area twice daily(morning and night) or as directed by a doctor.· supervise children in the use of this product.
· for athlete's foot: pay special attention to spaces between the
toes; wear well-fitting, ventilated shoes, and change shoes and
socks at least once daily.
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch,
use daily for 2 weeks.
if condition persists longer, consult a doctor.
· this product is not effective on the scalp or nails.
Indications & Usage
When using this product
avoid contact with the eyes.
Stop use andask a doctor if
irritation occurs.
there is no improvement within 4 weeks (for athlete's foot and
ringworm) or 2 weeks (for jock itch).
Inactive Ingredient
Purified Water, Caprylic/Capric Triglyceride, Glycerin, AloeBarbadensis Leaf Juice, Cetearyl Alcohol, Propylene Glycol, GlycerylStearate, Squalane, Panthenol, PEG-100 Stearate, Dimethicone,Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil,Calendula Officinalis Flower Extract, Carbomer, Allantoin,Tocopherol, Ethylhexylglycerin
* Please review the disclaimer below.
