Lucky Supersoft
FDA Label NDC 47046-173

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd. for the product Lucky Supersoft (NDC 47046-173). 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, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

■ cures most athlete's foot, jock itch, and ringworm ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only.

Do Not Use

children under 2 years of age unless directed by a doctor

When Using This Product

avoid contact with eyes

Stop Use And Ask A Doctor If

■ irritation occurs ■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (jock itch)

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

■ wash affected area and dry thoroughly ■ apply a  thin layer over affected area twice daily  (morning and night) ■ 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 a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

Other Information

■  store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

benzyl alcohol, cetearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

Package Label

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