Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)
Hakimian Global LLC
TOPICAL
OTC DRUG
External Analgesic For temporary relief of pain In large quantities, particularly over raw surfaces or blistered areas.• If condition worsens or if symptoms persist for more than 7 days or clear up and ocur again within a few days, discontinue use of this product and consult a doctor.
OTC monograph not final
ARTHRONEO- CAMPHOR SPRAY HAKIMIAN GLOBAL LLC _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._ ---------- ARTHRONEO (HAKIMIAN GLOBAL LLC | 82225-001-50) ACTIVE INGREDIENT Camphor 0.50% PURPOSE External Analgesic USES For temporary relief of pain WARNINGS For external use only. DO NOT USE In large quantities, particularly over raw surfaces or blistered areas.• If condition worsens or if symptoms persist for more than 7 days or clear up and ocur again within a few days, discontinue use of this product and consult a doctor. WHEN USING THIS PRODUCT Avoid contact with the eyes STOP USING AND ASK A DOCTOR if irritation or rash occurs. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center 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: consult a doctor. OTHER INFORMATION Keep dry. Store at 5'C and 20'C. INACTIVE INGREDIENTS Sensil CH SP, Amica montana flower extract, Benzyl alcohol, Citric acid, Disodium EDTA, Limonene, Lavandula angustifolia herb oil, Linalool, Peg-40 hydrogenated castor oil, Potassium sorbate, Propylene glycol, Sodium benzoate, Water PRINCIPAL DISPLAY Made in the EU Manufacturered for Likasso, LTD Grafenberger Alle 115 4023 Dusseldorf, Germany NDC: 82225-001-50 ARTHRONEO camphor spray PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:82225-001 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 g in 100 g Hakimian Global LLC INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BENZYL ALCOHOL (UNII: LKG8494WBH) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH Read the complete document