Your browser does not support JavaScript! DOUBLE PRAWN BRAND HERBAL OIL (BENZOCAINE, MENTHOL) OIL [TAI TONG AH CO PTE LTD]
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DOUBLE PRAWN BRAND HERBAL OIL (benzocaine, menthol) oil
[Tai Tong Ah Co Pte Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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

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DOUBLE PRAWN BRAND HERBAL OIL 
benzocaine, menthol oil
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:14720-372
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
DICTAMNUS DASYCARPUS WHOLE 
COMMIPHORA MYRRHA WHOLE 
SOPHORA FLAVESCENS WHOLE 
SANGUISORBA OFFICINALIS WHOLE 
GLEDITSIA SINENSIS WHOLE 
RHEUM PALMATUM WHOLE 
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14720-372-301 in 1 CARTON
1NDC:14720-372-2928 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/27/2004
Labeler - Tai Tong Ah Co Pte Ltd (595198821)
Registrant - Tai Tong Ah Co Pte Ltd (595198821)
Establishment
NameAddressID/FEIBusiness Operations
Tai Tong Ah Co Pte Ltd595198821manufacture(14720-372)

Revised: 11/2013
 
Tai Tong Ah Co Pte Ltd

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