BON BALM PENETRATING PAIN RELIEF- menthol methyl salicylate oil 
PMC TRADE, EXPORT AND IMPORT

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

Camphor 6%

Menthol 1.25%

Purpose

External Analgesic

External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

For external use only ■ Avoid getting into the eyes or on mucous membranes

■ Discontinue use if excessive irritation of the skin develops

When using this product

■ Do not apply to wound or damaged skin.

■ Do not bandage tightly

Stop use and ask a doctor if

■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

■ Pain persists for more than 10 days conditions

■ Redness is present

■ Conditions affect children under 12 years of age

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

Directions

■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily

■ Apply liberally and gently rub into affected area

■ Children under 12 years of age, consult a doctor before using

Inactive ingredients

Grape Seed Oil, Lemon Oil, Pine Needle Oil, Sesame Oil, Sunflower Oil, Sweet Almond Oil

Package Label

image description

BON BALM  PENETRATING PAIN RELIEF
menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68973-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE SEED OIL (UNII: 930MLC8XGG)  
LEMON OIL (UNII: I9GRO824LL)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
SESAME OIL (UNII: QX10HYY4QV)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALMOND OIL (UNII: 66YXD4DKO9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68973-001-011 in 1 BOX
1NDC:68973-001-6060 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/15/2014
Labeler - PMC TRADE, EXPORT AND IMPORT (179635003)

Revised: 6/2014
Document Id: f18f14a5-84ba-47a4-bc6c-23f5c232a8c5
Set id: 859f1d35-a24e-4020-8871-8cfe36680b87
Version: 1
Effective Time: 20140627
 
PMC TRADE, EXPORT AND IMPORT