Indo Abadi Sari Makmur, PT

Indo Abadi Sari Makmur, PT

Drug Labeling and Warnings

Drug Details

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BALM STICK- camphor, menthol, methyl salicylate stick 
Indo Abadi Sari Makmur, PT

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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Indo Abadi Sari Makmur, PT

Active Ingredients

Methyl Salicylate  7%

Menthol  13%

Camphor  12%

Purpose

Methyl Salicylate     External Analgesic

Menthol         External Analgesic

Camphor    External Analgesic

Uses

Relieves muscle pains, lumbago, insect bites, itching

DIRECTIONS

Apply to the affected area as needed.

Warnings

External Use Only. Do not use for children below 2 years of age. Avoid direct application into the nostrils.

Warnings

Keep out of reach of children.

Warnings

Stop use and ask 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, vomitting, abdominal discomfort, diarrhea, or skin rash occurs

When using for pain of arthritis: pain persits for more than 10 days, redness is present, in conditions affecting children 12 years of age.

Other Information

Keep container tightly closed. Store at 16 to 30 degrees centigrade (69 to 86 Farenheit).

Inactive Ingredients

Eucalyptus Oil, Capsicum, Peppermint Oil, Borneol

Drug Facts

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BALM STICK 
camphor, menthol, methyl salicylate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70815-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CAPSICUM (UNII: 00UK7646FG)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BORNEOL (UNII: M89NIB437X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70815-001-201 in 1 CARTON07/31/2016
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2016
Labeler - Indo Abadi Sari Makmur, PT (728715202)

Revised: 8/2016
 
Indo Abadi Sari Makmur, PT


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