Label: MAJOR CAMPHOR AND PHENOL - antiseptic liquid
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- NDC Code(s): 00904-7851-6, 00904-7851-7
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 17, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- USES
- first aid to help reduce the risk of infection associated with minor cuts, scrapes, minor burns, and insect bites
- for the temporary relief of pain and itching associated with minor burns, sunbrun, minor cuts, scrapes, fever blisters and cold sores
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away. Do not induce vomiting before contacting medical help or a Poison Control Center
Close - Directions
- clean the affected area
- adults and children 2 years of age or older: apply a small amount of this product on the area 1 to 3 times daily
- children under 2 years of age: consult a doctor
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
MAJOR CAMPHOR AND PHENOL
antiseptic liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:00904-7851 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10.8 g in 100 mL PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 4.7 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) LIGHT MINERAL OIL (UNII: N6K5787QVP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:00904-7851-6 1 in 1 CARTON 1 NDC:00904-7851-7 44 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 05/09/2008 Labeler - Major Pharmaceuticals (191427277) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations Major Pharmaceuticals 191427277 label(00904-7851) CloseEstablishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 pack(00904-7851) , manufacture(00904-7851)
