Label: THAI HERBAL BALM LEMON GRASS (menthol and camphor- synthetic ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 75978-3048-1, 75978-3048-2 - Packager: Thai Herb and Spa
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 26, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Ingredients
- Use(s)
- Directions
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Warnings
For external use only
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 50g Jar
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INGREDIENTS AND APPEARANCE
THAI HERBAL BALM LEMON GRASS
menthol and camphor (synthetic) ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75978-3048 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 5 g in 50 g Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate 6 g in 50 g Inactive Ingredients Ingredient Name Strength West Indian Lemongrass Oil (UNII: 5BIA40E9ED) 2.5 g in 50 g Peppermint Oil (UNII: AV092KU4JH) 2.5 g in 50 g Camphor (synthetic) (UNII: 5TJD82A1ET) 1.5 g in 50 g Paraffin (UNII: I9O0E3H2ZE) 7.5 g in 50 g Petrolatum (UNII: 4T6H12BN9U) 27.5 g in 50 g Product Characteristics Color white (white cream) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75978-3048-1 1 in 1 BOX 1 50 g in 1 JAR 2 NDC:75978-3048-2 1 in 1 BOTTLE 2 20 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/09/2007 Labeler - Thai Herb and Spa (195629303) Establishment Name Address ID/FEI Business Operations THANYAPORN HERBS CO.,LTD. 660966151 manufacture(75978-3048)