MATA BALM - camphor, menthol ointment 
Amata LLC

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 Ingredient

Camphor 4.5%

Menthol 37%

Purpose

Topical  Analgesic 

Keep out of reach of children

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

Uses

For temporarily relief of pain and itching associated with insect bites,minor skin irritations and infections,

rashes, boils, minor aches and pains of muscles and joints, dizziness

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Directions


Apply thin layer to or rub gently upon the desired area or inhale as needed. Repeat 3 to 4 times daily. For infants under 12 months of age, consult physician before use


Inactive Ingredients


Aloe Vera, Barleria Lupulina, Beach Morning Glory, Betel leaf, Clinacanthus Nutans Lindau, Coconut oil, Crinum Veld Lily, Garden Quinine, Paraffin, Petrolatum,Zingiber Cassamunar.



Other Information:

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

Store at 68° to 85°F (20° to 30°C)


Drug Label

MATA BALM 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58167-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)45 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL367 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BARLERIA PRIONITIS WHOLE (UNII: 8GSN1J79JM)  
IPOMOEA PES-CAPRAE FLOWERING TOP (UNII: 0SJ345C829)  
PIPER BETLE LEAF (UNII: NT24A1359E)  
CAJANUS CAJAN LEAF (UNII: DP2IW63584)  
COCONUT OIL (UNII: Q9L0O73W7L)  
QUININE (UNII: A7V27PHC7A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
ZINGIBER MONTANUM FLOWERING TOP (UNII: P614KWN5QY)  
CRINUM ASIATICUM WHOLE (UNII: 4A0W54S52I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58167-112-301 in 1 BOX
130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/27/2013
Labeler - Amata LLC (078743307)
Establishment
NameAddressID/FEIBusiness Operations
Sopa Suthayalai661732799manufacture(58167-112)

Revised: 5/2013
Document Id: 635414da-adef-4eac-be68-daf3f35f892e
Set id: 56f84aae-ea47-4207-80da-3657bc1e0af2
Version: 2
Effective Time: 20130511
 
Amata LLC