Ultra Balm Ointment
FDA Label NDC 57598-888

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ling Nam Medicine Factory (h.k.) Ltd. for the product Ultra Balm (NDC 57598-888). 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 other, otc - purpose, uses, warnings, allergy alert, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Warnings

→ Allergy Alert

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 19.8 G Jar Carton

Other

Drug Facts

Otc - Purpose

Active Ingredients	Purpose
Menthol 14%	Topical analgesic
Methyl Salicylate 23.2%	Topical analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Allergy Alert

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When Using This Product

use only as directed
avoid contact with eyes or mucous membranes
do not apply to wounds, damaged or irritated skin
do not bandage tightly or use with heating pad
do not use 1 hour prior to bathing or 30 minutes after bathing

Stop Use And Ask A Doctor If

condition worsens
skin irritation or redness develops
pain persists for more than 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

for adults and children 12 years of age and over, apply to affected area not more than 3 to 4 times daily
for children 12 years or younger, consult a doctor before use
not intended for children under two years of age