Calmara by Dynarex Corporation CALMARA lotion

Calmara by

Drug Labeling and Warnings

Calmara by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Camphor 0.5%

Purpose

External Analgesic

Uses

For temporary relief of pain and itching associated with

minor burns

minor cuts

insect bites

sunburn

scrapes

minor skin irritations

Warnings

For external use only

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

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.

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) right away.

Directions

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

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

Avoid excessive heat

Tamper evident. Do not use if seal is damaged.

Inactive ingredients

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?

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

Label

INGREDIENTS AND APPEARANCE

CALMARA 
calmara lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCOL STEARATE (UNII: 0324G66D0E)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
PEG-4 DILAURATE (UNII: KCR71CW036)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
IMIDAZOLIDINYL UREA (UNII: M629807ATL)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM CETEARYL SULFATE (UNII: 7ZBS06BH4B)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-017-02	24 in 1 CASE	01/21/2026
1	NDC: 67777-017-01	221.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/21/2026

Labeler - Dynarex Corporation (008124539)