Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)
OraLabs
TOPICAL
OTC DRUG
External Analgesic For the temporary relief of pain and itching associated with cold sores and fever blisters. First Aid to help prevent infection.
OTC monograph final
CHAPICE CAMPHOR PHENOL GEL- CAMPHOR, PHENOL GEL ORALABS _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._ ---------- DRUG FACTS ACTIVE INGREDIENT Camphor 10.8%, Phenol 4.7% PURPOS E External Analgesic KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting medical help or a Poison Control Center. For adults and children over 2 years of age. US ES For the temporary relief of pain and itching associated with cold sores and fever blisters. First Aid to help prevent infection. WARNINGS For external use only. Do not use over large areas of the body or with a bandage. Ask a doctor before use if you have a deep puncture wound, animal bites, or serious burns. When using this product: avoid contact with eyes. Rinse with water to remove. Seek medical help or contact a Poison Control Center. Stop use and consult a doctor if: conditions worsen or last more than 7 days, or if it clears up and returns again in a few days. DIRECTIONS Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage. INACTIVE INGREDIENTS Colloidal Silicon Dioxide, Eucalyptus Oil, Glycerin, Light Mineral Oil PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CHAPICE CAMPHOR PHENOL GEL camphor, phenol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 36 45-16 0 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD8 2A1ET) CAMPHOR (SYNTHETIC) 10 .8 mg in 1 g PHENO L (UNII: 339 NCG44TV) (PHENOL - UNII:339 NCG44TV) PHENOL 4.7 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH LIGHT MINERAL O IL (UNII: N6 K578 7QVP) 77.75 mg in 1 g SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) 5.75 mg Read the complete document