Cramergesic

Manufacturer
The Hygenic Company, LLC | Pure Source, LLC
Effective date
2025-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:47:18

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

OTC - ASK DOCTOR SECTION

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 is excessive irritation of skin develops. Use with caution on sensitive 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

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1923242CRAMERGESIC 1.9 % / 13.7 % Topical OintmentPSN3
1376499menthol 1.9 % / methyl salicylate 13.7 % Topical OintmentPSN3
1923242menthol 0.019 MG/MG / methyl salicylate 0.137 MG/MG Topical Ointment [Cramergesic]SBD3
1376499menthol 0.019 MG/MG / methyl salicylate 0.137 MG/MG Topical OintmentSCD3
1923242Cramergesic (menthol 1.9 % / methyl salicylate 13.7 % ) Topical OintmentSY3
1376499menthol 1.9 % / methyl salicylate 13.7 % Topical OintmentSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311960045131GTIN-13: 0311960045131
EAN-13: 0311960045131
GTIN-12: 311960045131
UPC-A: 311960045131
GTIN storage (14 digits): 00311960045131
Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-854-01Cramergesic454 g in 1 JAROINTMENT4543

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82345-85482345-854-01

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
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
ndc (package): 82345-854-01
ndc (product): 82345-854
ndc11 (package): 82345085401
spl id: 410a1a4a-10dd-0fb2-e063-6294a90a82c7
spl set id: d0ffde7a-6942-74fc-e053-2a95a90a484a

Reported adverse events (FAERS/openFDA)#

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