THAI HERBAL BALM LAVENDER (menthol and camphor- synthetic ointment

Thai Herbal Balm Lavender by

Drug Labeling and Warnings

Thai Herbal Balm Lavender by is a Otc medication manufactured, distributed, or labeled by Thai Herb and Spa, THANYAPORN HERBS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Thai Herbal Balm Lavender

Ingredients

• Active Ingredients: Purpose
• Menthol 10%: Topical analgesic
• Methyl Salicylate: Topical analgesic

Use(s)

For sore muscles and over-exertion.

Provides sooting relief for aches and pains due to:

• Backaches
• Arthritis
• Joint Pains
• Stiffness
• Sprains
• Over-exertion
  

Directions

• Adults and children 12 years of age and older : Apply Thai Herbal Balm Lavender to affected area. Rub well on the affected area. Repeat 3 to 4 times daily.
• Children under 12 years of age: ask a doctor before use.
  

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.
  

Ask a doctor before

use if you have redness over the affected area.

When using this product

• Avoid contact with the eyes or mucous membranes
• Do not bandage tightly
  

Stop use and ask a doctor if

• Condition worsens or symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days
• Excessive skin irritation occurs
  

Keep out of reach of children to avoid accidental ingestion.

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

Other Information

• This product may cause an allergic reaction in some individuals. Test on a small area before use.
  

Inactive Ingredients

Peppermint Oil, Camphor And Paraffin Petrolatum.

PRINCIPAL DISPLAY PANEL - 50g Jar

THAI HERBAL BALM

LAVENDER

PAIN RELIEVING OINTMENT

NET WT. 1.75 oz. (50g)

INGREDIENTS AND APPEARANCE

THAI HERBAL BALM LAVENDER 
menthol and camphor (synthetic) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75978-3049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2.5 g  in 50 g
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET)	Camphor (synthetic)	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Lavender Oil (UNII: ZBP1YXW0H8)	2.5 g  in 50 g
Peppermint Oil (UNII: AV092KU4JH)	2.5 g  in 50 g
Methyl Salicylate (UNII: LAV5U5022Y)	6 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: 75978-3049-1	1 in 1 BOX
1		50 g in 1 JAR
2	NDC: 75978-3049-2	1 in 1 BOX
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