Cramergesic Ointment
FDA Label NDC 82345-854

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Hygenic Company, Llc for the product Cramergesic (NDC 82345-854). 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, consult a doctor, keep this and all drugs out of the reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 1.9%

Methyl Salicylate 13.7%

Purpose

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, and arthritis.
Combined with stretching and calisthenics, Cramergesic assists in the warm-up process, especially in cool, damp weather. Do not bandage tightly.

Warnings

For external use only.

Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor.

Consult A Doctor

before administering to children, including teenagers, with chicken pox or flu.

Keep This And All Drugs Out Of The Reach Of Children

to avoid accidental poisoning.

Directions

Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply Cramergesic pack: spread 1/8 " layer of Cramergesic over area. Do not bandage tightly.

Other Information

Discontinue use is excessive irritation of skin develops. Use with caution on sensitive skin. Store in a cool, dry place with cap closed tightly.

Inactive Ingredients

Lanolin, Paraffin, Petrolatum

Questions?

(800) 345-2231

Package Labeling:

Label6 (Label6)

Label6 (Label6)

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