1200 calmara

1200 calmara
SPL v2
SPL
SPL Set ID 487393e9-6619-6033-e063-6294a90a68b2
Route
topical
Published
Effective Date 2026-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (0.5 mg)
Inactive Ingredients
petrolatum mineral oil peg-40 castor oil propylparaben edetate disodium glycol stearate menthol water peg-4 dilaurate methylparaben propylene glycol stearic acid triethanolamine imidazolidinyl urea carbomer 940 sodium cetearyl sulfate cetearyl alcohol dimethicone

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
otc monograph drug active Since 2026-01-21
Purpose

External Analgesic

Description

Camphor 0.5%

Medication Information

Warnings

For external use only

Uses

For temporary relief of pain and itching associated with

• minor burns

• minor cuts

• insect bites

• sunburn

• scrapes

• minor skin irritations

Purpose

External Analgesic

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

Description

Camphor 0.5%

Questions?

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

Label

Section 53414-9

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

Active Ingredient

Camphor 0.5%

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.

Keep Out of Reach of Children

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

Structured Label Content

Warnings

For external use only

Uses

For temporary relief of pain and itching associated with

• minor burns

• minor cuts

• insect bites

• sunburn

• scrapes

• minor skin irritations

Purpose

External Analgesic

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 (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 (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

Section 53414-9 (53414-9)

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

Active Ingredient (Active ingredient)

Camphor 0.5%

When Using This Product (When using this product)

• Avoid contact with the eyes

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.602441 · Updated: 2026-03-14T23:12:30.242816