MATA BALM- camphor, menthol ointment

Mata Balm by

Drug Labeling and Warnings

Mata Balm by is a Otc medication manufactured, distributed, or labeled by Amata LLC, Sopa Suthayalai. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Use only as directed
• Do not apply to wounds and broken skin
• Avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• severe skin irritation occurs
• symptoms persist for more than 7 days or clear up and reoccur within a few days

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.

STORAGE AND HANDLING

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MATA BALM 
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58167-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	45 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	367 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58167-112-30	1 in 1 BOX
1		30 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/27/2013

Labeler - Amata LLC (078743307)

Establishment
Name	Address	ID/FEI	Business Operations
Sopa Suthayalai		661732799	manufacture(58167-112)