DOUBLE PRAWN BRAND HERBAL OIL- 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

image

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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14720-372-30 1 in 1 CARTON
1 NDC:14720-372-29 28 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 12/27/2004
Labeler - Tai Tong Ah Co Pte Ltd (595198821)
Registrant - Tai Tong Ah Co Pte Ltd (595198821)
Establishment
Name Address ID/FEI Business Operations
Tai Tong Ah Co Pte Ltd 595198821 manufacture(14720-372)

Revised: 11/2013
Document Id: 53601099-5e12-4e1a-82dc-2fc3f08128fa
Set id: 9c31740f-3dd3-4b0c-8b15-75a28af01f00
Version: 2993
Effective Time: 20131111
 
Tai Tong Ah Co Pte Ltd