JOSEPHS LION- camphor and menthol lotion

JOSEPHS LION by

Drug Labeling and Warnings

JOSEPHS LION by is a Otc medication manufactured, distributed, or labeled by CHAN YAT HING MEDICINE FACTORY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Camphor 3.5%
Menthol 5%

PURPOSE

Purpose
External analgesic

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use

• on wounds
• on irritated or damaged skin
• otherwise than as directed

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• do not bandage tightly

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive irritation of the skin develops

when using for pain of arthritis:

• pain persists for more than 10 days
• redness is present
• in conditions affecting children under 12 years of age

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.
• children under 3 years of age: do not use, consult a physician.
• refer to the above warnings; use otherwise than as directed may be dangerous.

STORAGE AND HANDLING

Other information
keep container tightly closed
store at 15E to 30 C (59 to 86 F)

INACTIVE INGREDIENT

Inactive ingredients
Anise oil, cajuput oil, lavender oil, methyl salicylate,and mineral oil.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache, arthritis, strains, bruises, sprains

PRINCIPAL DISPLAY PANEL

JOSEPH’S LION OIL, PAIN RELIEVING LOTION, NDC: 53196-001-01, 2 fl oz (60 mL)

INGREDIENTS AND APPEARANCE

JOSEPHS LION 
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53196-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ANISE OIL (UNII: 6Y89129C8H)
CAJUPUT OIL (UNII: J3TO6BUQ37)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53196-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/28/2012

Labeler - CHAN YAT HING MEDICINE FACTORY (680069367)

Registrant - CHAN YAT HING MEDICINE FACTORY (680069367)

Establishment
Name	Address	ID/FEI	Business Operations
CHAN YAT HING MEDICINE FACTORY		680069367	manufacture(53196-001)