Cramergesic Ointment

Manufacturer
Performance Health, LLC
Effective date
2022-08-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:55:45

Label at a glance#

ProductCramergesic
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.9%

Methyl Salicylate 13.7%

Purpose

OTC - PURPOSE SECTION

Counterirritant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

to avoid accidental poisoning.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Paraffin, Petrolatum

Questions?

OTC - QUESTIONS SECTION

(800) 345-2231

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-99859316-998-96, 59316-998-97

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e5b32c77-40ca-f645-e053-2995a90ad2966f32180a-e645-43b6-a854-6a5c66dd37982022-08-07WarningsExact identifier
spl id: e5b32c77-40ca-f645-e053-2995a90ad296
spl set id: 6f32180a-e645-43b6-a854-6a5c66dd3798

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.