ELECTRIC MEDICATED BALM- menthol and methyl salicylate ointment

ELECTRIC MEDICATED BALM by

Drug Labeling and Warnings

ELECTRIC MEDICATED BALM by is a Otc medication manufactured, distributed, or labeled by FEI FAH MEDICAL MANUFACTURING PTE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Menthol 11%
Methyl salicylate 22%

PURPOSE

Purpose
External analgesic
External 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 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.

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients   Petrolatum

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

ELECTRIC MEDICATED BALM
External Analgesic
NDC: 63299-046-04
NET 2.45 oz (70g)

INGREDIENTS AND APPEARANCE

ELECTRIC MEDICATED BALM 
menthol and methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63299-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	11 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63299-046-01	1 in 1 BOX	02/13/2008
1		19 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 63299-046-04	1 in 1 BOX	02/13/2008
2		70 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 63299-046-05	1 in 1 BOX	02/13/2008
3		10 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/13/2008

Labeler - FEI FAH MEDICAL MANUFACTURING PTE LTD (628416141)

Establishment
Name	Address	ID/FEI	Business Operations
FEI FAH MEDICAL MANUFACTURING PTE LTD		628416141	manufacture(63299-046)