Lucky Supersoft
FDA Label NDC 47046-177

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 47046-177). 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 ingredients, 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 Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with :

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

For external use only

Do Not Use

■ on wounds or damaged skin ■ with a heating pad

■ on a child under 12 years of age with arthritis like conditions

When Using This Product

■ avoid contact with eyes or mucous membranes ■ do not bandage tightly

Stop Use And Ask A Doctor If

■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

■ excessive skin irritation occurs

Keep Out Of Reach Of Children

to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 time daily

■ children under 12 years of age: ask a doctor

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

carbomer 940, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

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