DOUBLE PRAWN BRAND HERBAL OIL- benzocaine, menthol oil
Tai Tong Ah Co Pte Ltd

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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Double Prawn Brand Herbal Oil

ACTIVE INGREDIENTS

Menthol 3.5%

PURPOSE

Menthol External Analgesic

USE

For the relief from pain, swelling and itching due to skin irritation, skin infection, minor cuts, fungal infection, abrasions, bruises, minor burns and scalds, insect bites and a range of skin problems.

WARNING

For external use only and use as directed. Avoid contact with eyes, mucous membrances or rashes, wounds or damage skin. Do not use with a heated pad.

WARNING

Keep out of reach of children. If swallowed, get medical help immediately.

WARNING

Stop use and consult a doctor if excessive irritaion of the skin develops. For children under 2 years of age, consult a doctor.

DIRECTIONS

Apply Herbal Oil to the affective area several times; use cotton dressing if necessary, repeat several times until completely healed.

DIRECTIONS

Apply Herbal Oil several times daily.

STORAGE

Store at cool and dry place from direct sunlight.

INACTIVE INGREDIENT

Camphor, dictampus dasycarpus, commiphora myrrha, sophora flavescens, sanguisorba officinalis, gleditsia sinensis, rheum palamatum

DRUG FACTS

DOUBLE PRAWN BRAND HERBAL OIL
benzocaine, menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14720-372
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DICTAMNUS DASYCARPUS WHOLE (UNII: IM7ZCU30YH)
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
SANGUISORBA OFFICINALIS WHOLE (UNII: J578M57Q8Z)
GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)
RHEUM PALMATUM WHOLE (UNII: 75P857ARCY)

Product Characteristics
Color	white	Score
Shape	ROUND	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14720-372-30	1 in 1 CARTON
1	NDC:14720-372-29	28 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	12/27/2004

Labeler - Tai Tong Ah Co Pte Ltd (595198821)

Registrant - Tai Tong Ah Co Pte Ltd (595198821)

Name	Address	ID/FEI	Business Operations
Establishment
Tai Tong Ah Co Pte Ltd		595198821	manufacture(14720-372)