AXE BRAND MEDICATED- menthol, camphor and methyl salicylate oil 
LEUNG KAI FOOK MEDICAL CO PTE LTD

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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DRUG FACTS

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

Purpose
External analgesic

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

Warnings
For external use only

Do not use
on wounds
on irritated or damaged skin
on the face
otherwise than as directed

When using this product
avoid contact with the eyes or mucous membranes
do not bandage tightly

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 to avoid accidental poisoning
If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Inactive ingredients
Eucalyptus oil, lavender oil and mineral oil.

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

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

AXE BRAND MEDICATED 
menthol, camphor and methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57538-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 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 SALICYLATE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57538-003-0156 mL in 1 PACKAGE; Type 0: Not a Combination Product04/13/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/13/2001
Labeler - LEUNG KAI FOOK MEDICAL CO PTE LTD (595107004)
Establishment
NameAddressID/FEIBusiness Operations
LEUNG KAI FOOK MEDICAL CO PTE LTD595107004manufacture(57538-003)

Revised: 11/2019
Document Id: 3294993c-17d8-4ee3-99e7-d33b8751f3af
Set id: e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0
Version: 2
Effective Time: 20191113
 
LEUNG KAI FOOK MEDICAL CO PTE LTD