Label: LEADER CAMPHOR SPIRIT (camphor- natural liquid
- NDC Code(s): 37205-009-16
- Packager: Cardinal Health
- 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 July 19, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only.
Do not drink. If swallowed, immediately give 3 or 4 glasses of water. Do not induce vomiting. If vomiting occurs, give fluids again. Do not give anything by mouth to an unconscious or convulsing person. Get medical attention immediately.
Avoid contact with eyes or mucous membranes.
Do not apply to irritated skin.
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LEADER CAMPHOR SPIRIT
camphor (natural) liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-009-16 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/30/2018 10/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/30/2018 10/31/2023 Labeler - Cardinal Health (097537435) Registrant - Humco Holding Group, Inc (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc 825672884 manufacture(37205-009) , analysis(37205-009) , pack(37205-009) , label(37205-009)