LEADER Camphor Spirit (New NDC)

LEADER CAMPHOR SPIRIT- camphor (natural) liquid
Cardinal Health, 110 dba Leader

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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(Dillute with 3 parts olive oil and mix well)

Adults and children 2 yrs. and older apply to the affected area not more than 3 or 4 times daily.

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

Alcohol 84%, Purified Water

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.

External Analgesic

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.

For the temporary relief of minor aches, muscle and jooint pain associated with artritis, strains, bruises and simple backache

Camphor 10%

label

LEADER CAMPHOR SPIRIT
camphor (natural) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0396
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0396-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/17/2018

Labeler - Cardinal Health, 110 dba Leader (063997360)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(70000-0396) , analysis(70000-0396) , pack(70000-0396) , label(70000-0396)