Calmara

Manufacturer
Dynarex Corporation
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:54

Label at a glance#

ProductCalmara
Active ingredientCAMPHOR (NATURAL)
Label structure9 sections

Indications and uses

For temporary relief of pain and itching associated with • minor burns • minor cuts • insect bites • sunburn • scrapes • minor skin irritations

Dosage and administration

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.5%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with

• minor burns

• minor cuts

• insect bites

• sunburn

• scrapes

• minor skin irritations

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

• Avoid contact with the eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Other information

OTHER SAFETY INFORMATION

• Store at room temperature 15°-30°C (59°-86°F)

• Avoid excessive heat

• Tamper evident. Do not use if seal is damaged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, cetearyl alcohol, dimethicone, disodium EDTA, glycol stearate, imidazolidinyl urea, menthol, methylparaben, mineral oil, PEG-4 dilaurate, PEG-40 castor oil, petrolatum, propylene glycol, propylparaben, sodium cetearyl sulfate, stearic acid, titanium dioxide, triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1200_IN_MASTER1200_IN_MASTER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840117349186GTIN-13: 0840117349186
EAN-13: 0840117349186
GTIN-12: 840117349186
UPC-A: 840117349186
GTIN storage (14 digits): 00840117349186
1200_IN_MASTER_R251126-6.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-017-01Calmara221.8 mL in 1 BOTTLE, PUMPLOTION221.82
67777-017-02Calmara24 in 1 CASELOTION242

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-01767777-017-01, 67777-017-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
CalmaraCALMARADynarex Corporation487393e9-6619-6033-e063-6294a90a68b22026-01-16WarningsExact identifier
ndc (package): 67777-017-02
ndc (package): 67777-017-01
ndc (product): 67777-017
ndc11 (package): 67777001702
ndc11 (package): 67777001701
spl id: 488e4308-742f-88af-e063-6394a90a7dda
spl set id: 487393e9-6619-6033-e063-6294a90a68b2

Reported adverse events (FAERS/openFDA)#

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