LEADER CAMPHOR SPIRIT (camphor- natural liquid

LEADER Camphor Spirit by

Drug Labeling and Warnings

LEADER Camphor Spirit by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

(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.

INACTIVE INGREDIENT

Alcohol 84%, Purified Water

KEEP OUT OF REACH OF CHILDREN

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.

PURPOSE

External Analgesic

WARNINGS

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.

INDICATIONS & USAGE

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

ACTIVE INGREDIENT

Camphor 10%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER CAMPHOR SPIRIT 
camphor (natural) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0396
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: 70000-0396-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2018

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

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	manufacture(70000-0396) , analysis(70000-0396) , pack(70000-0396) , label(70000-0396)