Pain Relieving Cream
FDA Label NDC 70000-0744

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Pain Relieving (NDC 70000-0744). 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, allergy alert!, when using this product, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Allergy Alert!

→ When Using This Product

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

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Active Ingredients

Trolamine Salicylate

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and pains associated with simple backache, arthritis, 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 • avoid contact with the eyes • do not use at the same time as other topical analgesics • do not apply to wounds or damaged skin • do not bandage tightly • do not use with heating pads or other heating devices. • Use only as directed. Read and follow all directions and warnings.

Stop use and ask a doctor • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Allergy Alert!

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

When Using This Product

use only as directed. Read an follow all directions and warnings on this label
do not bandage tightly or apply local heat (such as heating pads) to the area of use
avoid contact with eyes and mucous membranes
do not apply to wounds or damaged, broken or irritated skin
do not use at the same time as other topical analgesics

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
children under 12 years of age: do not use, consult a doctor

Inactive Ingredients

aloe barbadensis leaf extract, cetyl alcohol, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, sodium hydroxide, stearic acid, water.