Active Ingredient(S)
Clotrimazole 1%
Seebeellar Clotrimazole 1% Antifungal Cream
FDA Label NDC 84558-014
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 Seebeellar Clotrimazole 1% Antifungal Cream (NDC 84558-014). 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
Uses: Treats skin fungal infections: jock itch (tinea cruris), athlete's foot
(tinea pedis), ringworm (tinea corporis).Relieves itching, redness,
burning, and irritation from fungal infections. Soothes skin and sup-
ports recovery in moisture/friction-prone areas (groin, inner thighs,
body folds)
Warnings
Warnings: For external use only.
Do Not Use
Do not use: on broken, iflamed, or severely rritated skin; or if allergic
to Clotrimazole/any ingredients.
Otc - When Using
When using this product: Avoid contact with eyes. lf contact occurs,
rinse thoroughly with water.
Otc - Stop Use
Stop use & ask a doctor if: irritation/rash develops; condition wors-
ens or no improvement within 2 weeks. If pregnant or breastfeeding, ask
a healthcare professional before use. Keep out of reach of children. lf
swallowed, get medical help or contact a Poison Control Center imme-
diately.
Otc - Keep Out Of Reach Of Children
Children Under 12: Consult a doctor before use.
Directions
Directions: Adults & Children 12+; Clean and dry the affected area
thoroughly; Apply a thin layer of cream twice daily (morning & night);
Continue use for up to 2 weeks, or as directed by a doctor; Wear
loose-fitting clothing to keep the area dry
Other Information
Other Information: Store between 20° -27°C (68° -81°F); See top panel
for lot number and expiration date
Inactive Ingredients
Aqua、Urea、Glycerin、Propylene Glycol、Cetearyl Alcohol、Ethylhexyl Palmitate、
Caprylic/Capric Triglyceride、Dimethicone、C14-22 Alcohols、 Betaine、Trehalose、
Butyrospermum Parkii (Shea) Butter、Cocos Nucifera (Coconut) Oil、Dextrin、Panthenol、
Phenoxyethanol、Potassium Cetyl Phosphate、C12-20Alkyl Glucoside、Salicylic Acid、
Hydroxyacetophenone、Allantoin、Carbomer、Tocopheryl Acetate、Triethanolamine、
Melaleuca Alternifolia (Tea Tree) Leaf Oil、Polysorbate 80、Mentholum、Butylene Glycol、
Propanediol、Xanthan Gum、o-Cymen-5-ol、Fragrance、Sodium Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer、Polyglyceryl-2 Isostearate、Chlorphenesin、
Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate、lsohexadecane、
Madecassoside、Glycyrrhiza Inflata Extract、 Centella Asiatica Extract、Sesame Amino
Acids、Gentiana Scabra Root Extract、Sophora Flavescens Extract、Chamomilla Recutita
(Matricaria) Flower Extract、Sophora Angustifolia Root Extract
Package Label - Principal Display Panel
Undefined (Label)
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