MENTHOL AND METHYL SALICYLATE- electric medicated balm ultra strength ointment 
FEI FAH MEDICAL MANUFACTURING 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%
Methyl salicylate 32%

Purpose
External analgesic
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 small amount with your finger tip 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.

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

Inactive ingredients
Petrolatum

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

ELECTRIC MEDICATED BALM
External Analgesic
NDC 63299-001-01
NET 2.45 oz (70g)
Box1.jpg

MENTHOL AND METHYL SALICYLATE 
electric medicated balm ultra strength ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63299-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE32 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63299-001-011 in 1 BOX03/28/2018
170 g in 1 JAR; Type 0: Not a Combination Product
2NDC:63299-001-021 in 1 BOX03/28/2018
210 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/28/2018
Labeler - FEI FAH MEDICAL MANUFACTURING PTE LTD (628416141)
Establishment
NameAddressID/FEIBusiness Operations
FEI FAH MEDICAL MANUFACTURING PTE LTD628416141manufacture(63299-001)

Revised: 3/2018
Document Id: 310f812b-cd56-45f6-b022-26baff9f0cd0
Set id: 91e6d3b9-25bb-4015-9d96-bd27f93e5ada
Version: 1
Effective Time: 20180328
 
FEI FAH MEDICAL MANUFACTURING PTE LTD