MONKEY HOLDING PEACH BRAND EXTERNAL ANALGESIC BALM- camphor,menthol,methyl salicylate ointment 
P.S.W. INC.

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              22%

Menthol               16%

Methyl Salicylate  3%


Purpose

Topical Analgesic


Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.


Directions

Inactive Ingredients

Paraffin, Eucalyptus Oil, Cinnamon Oil, Peppermint Oil, Olive Oil.


Warnings

For External Use Only.

When using this product

  • Avoid contact with eyes or mucous membranes.
  • Do not apply to open wounds or damaged skin.
  • Do not bandage or use heating pad.

Stop use and ask a doctor

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persistes for more than seven days.
  • Pain clears up and then recurs a few days later

If pregnant or breast-feeding

ask a healthcare professional before use.


Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.


Other information

This product may cause allergic reaction in some individuals. test on small area before use.


Principal Display Panel

Monkey Holding Peach Brand External Analgesic Balm

Export USA

Net Wt. 0.283 fl.oz. (8g)

NDC 57373-108-01

Product of Thailand


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MONKEY HOLDING PEACH BALM EXTERNAL ANALGESIC BALM

Methyl Salicylate Camphor Menthol Eucalyptus Oil

Net Wt. 0.42 fl.oz. (12g)

NDC 57373-108-02

Product of Thailand


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MONKEY HOLDING PEACH BRAND  EXTERNAL ANALGESIC BALM
camphor,menthol,methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57373-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)22 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CLOVE OIL (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57373-108-018 g in 1 CAN
2NDC:57373-108-0212 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/14/2014
Labeler - P.S.W. INC. (802789420)

Revised: 4/2014
Document Id: 6cb7a46a-84aa-43fb-8da2-c33ddf573f0b
Set id: 2e153c5c-bb12-42db-bd70-c9b68a6ffa0f
Version: 1
Effective Time: 20140414
 
P.S.W. INC.