LEADER CAMPHOR SPIRIT- camphor (natural) liquid 
Cardinal Health

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.

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LEADER Camphor Spirit

Camphor 10%

For the temporary relief of minor aches, muscle and joint pain associated with arthritis, strains, bruises and simple backache.

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.

Counterirritant

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. In case of eye contact, flush eyes with running water for 15 minutes, get medical attention.

Alcohol 84%, Purified Water

(dilute 3 parts olive oil and mix well)


Adults and children 2 yrs, and older. Apply to the affected area no more than 3 or 4 times daily.

Children under 2 yrs of age: consult a doctor before use.

Leader Camphor SPirit

LEADER CAMPHOR SPIRIT 
camphor (natural) liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-009-1659 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/30/2018
Labeler - Cardinal Health (097537435)
Registrant - Humco Holding Group, Inc (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc825672884manufacture(37205-009) , analysis(37205-009) , pack(37205-009) , label(37205-009)

Revised: 8/2018
Document Id: 74aa0035-776e-a07b-e053-2a91aa0a0199
Set id: 7148cf01-d577-4f9d-bda8-6f5d40860d3f
Version: 2
Effective Time: 20180830
 
Cardinal Health