AXE BRAND MEDICATED- menthol, camphor and methyl salicylate oil

AXE BRAND MEDICATED by

Drug Labeling and Warnings

AXE BRAND MEDICATED by is a Otc medication manufactured, distributed, or labeled by LEUNG KAI FOOK MEDICAL CO PTE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Menthol 16%
Camphor 5%
Methyl salicylate 15%

PurposeExternal analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use
on wounds
on irritated or damaged skin
on the face
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
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

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 a few drops then gently rub into the affected area not more than 3 to 4 times daily.
Children under 3 years of age: Do not use, consult your doctor.
Refer to the above warnings; use otherwise than as directed may be dangerous

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive ingredients
Eucalyptus oil, lavender oil and mineral oil.

QUESTIONS

Questions or comments? (888)221-3496 M-F 9am to 5pm
you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

AXE BRAND MEDICATED OIL NDC-57538-003-1 1.89 fl oz (56mL)

INGREDIENTS AND APPEARANCE

AXE BRAND MEDICATED 
menthol, camphor and methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57538-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57538-003-01	56 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/13/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/13/2001

Labeler - LEUNG KAI FOOK MEDICAL CO PTE LTD (595107004)

Establishment
Name	Address	ID/FEI	Business Operations
LEUNG KAI FOOK MEDICAL CO PTE LTD		595107004	manufacture(57538-003)