ARNEU- camphor menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941), Menthol (UNII: L7T10EIP3A) (Alcohol - UNII:3K9958V90M)

Available from:

CC Medical Devices Inc

INN (International Name):

Camphor - UNII:N20HL7Q941)

Composition:

Camphor (Natural) 3.1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Topical Analgesic Topical Analgesic Uses For the temporary relief of minor aches and pains of muscles and joints. Penetrating pain relief.

Authorization status:

OTC monograph final

Summary of Product characteristics

ARNEU - CAMPHOR MENTHOL CREAM
CC MEDICAL DEVICES INC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
Active Ingredients
Camphor 3.100%
Menthol 3.000%
Purpose
Topical Analgesic
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and
joints.
Penetrating pain relief.
Warnings
For external use only.
Do not bandage tightly.
Do not apply heat to the area of application.
Do not apply to open wounds or damaged skin.
Avoid contact with eyes or mucous membranes.
Ask a doctor before use, if you have ever experienced a reaction due
to ingredients listed.
Stop use and consult a licensed health professional if conditions
worsens or if symptoms persists for
more than 7 days, or clears up and occurs again.
If pregnant or breast feeding, ask the health professional before use.
Keep out of reach of children.
If ingestion occurs, get medical help or contact a Poison Control
Center right away.
Directions
Adults and children 12 years of age or older
Apply to surface, leaving a thin visible film; by applying a thicker
film, the intensity is increased.
Apply to the area of pain, extending outside of the area slightly.
Apply 2 times a day minimum (do not exceed application of 4 times
daily).
Allow to dry completely before applying loose clothing over the area.
Directions
(Children 12 years of age or younger)
Ask your doctor or a licensed health professional.
Other Information
Store at 15-30 C (50-85 F). Keep sealed tightly.
No triethanolamine used in manufacturing.
Have all medical diagnosis confirmed by a healthcare professional
before treating.
Do not use if cap seal has been tampered with.
Inactive Ingredients
Water, propylene glycol, glycerin, witch hazel, carbomer, sodium
hydroxymethylglycinate, fragrance,
arnica montana flower extract, potassium asparate, sodium chlorite,
willow bark extract, green tea leaf
extract, sodi