Label: LEADER CAMPHOR PHENOL GEL- camphor, phenol gel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated April 22, 2014
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- Active ingredient
- Keep Out of Reach of Children
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 or puncture wound. Animal bites. Serious burns. When using this product do not use near the eye. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.
- Inactive Ingredients
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
LEADER CAMPHOR PHENOL GEL
camphor, phenol gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-751 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 mg in 1 g PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 4.7 mg in 1 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) 77.75 mg in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5.75 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) 0.5 mg in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) 0.500 mg in 1 g Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-751-23 1 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/15/2013 Labeler - Cardinal Health (Leader) (097537435) Registrant - Cardinal Health (Leader) (097537435) Establishment Name Address ID/FEI Business Operations OraLabs, Inc. 801824756 MANUFACTURE(37205-751) , LABEL(37205-751)