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Topical Analgesic Gel

Dosage form: gel
Ingredients: MENTHOL, UNSPECIFIED FORM 40mg in 1mL, CAMPHOR (NATURAL) 5mg in 1mL
Labeler: Supadelixir Co Ltd
NDC Code: 71200-405

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.

Topical Analgesic Gel

Drug Facts

Active Ingredients

MENTHOL 4% / Camphor 0.5%

Purpose

Topical Analgesic

USE

For the temporary relief of minor aches and pains of muscles and joints associated with ●Rheumatism ●Muscle strain ●Sprains ●Bruises ●Neck and Shoulder Stiffness ●The foot and leg after hard running

Warnings

For external use only

When using this product ● avoid contact with eyes and mucous membranes. ● do not apply to open wounds or damaged skin. ● make sure skin is clean and free of any creams ointments, sprays or liniments. ● do not cover with bandage. ● store in a cool, dry place. ● keep lid tightly closed. ● do not use with heating pads or heating devices.

Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more than 7 days.

Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

● Clean skin of all other lotions, creams, ointments, liniments

● Apply liberally to affected area and massage until gel is absorbed into skin by 3 or 4 times within a 24 hour period.

● No protective cover needed.

Inactive Ingredients

Water, Isopropyl Myristate, Aloe Barbadensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Water, Isopropyl Alcohol, Dimethyl Sulfone, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Silica, Glyceryl Caprylate, Tocopheryl Acetate, Ethylhexylglycerin, Palmitoyl sh- Tripeptide-4 Amide

Distributed by                                                          

SupadElixir Co., Ltd.

# 410, Building 1, School of Medicine,

1 Kangwondaehak-gil, Chuncheon-si,

Gangwon-do, Korea


www.SE-Tripeptide.com

MADE IN KOREA

External Analgesic

Advanced Pain Relieving Gel

for Aches & Pain

Packaging

TOPICAL ANALGESIC GEL 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71200-405
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL MYRISTATE 
ALOE VERA LEAF 
HAMAMELIS VIRGINIANA TOP WATER 
ISOPROPYL ALCOHOL 
DIMETHYL SULFONE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
CARBOXYPOLYMETHYLENE 
TROLAMINE 
SILICON DIOXIDE 
GLYCERYL MONOCAPRYLATE 
.ALPHA.-TOCOPHEROL ACETATE 
ETHYLHEXYLGLYCERIN 
PALMITOYL SH-TRIPEPTIDE-4 AMIDE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:71200-405-10100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/02/2017
Labeler - Supadelixir Co Ltd (688481952)
Establishment
NameAddressID/FEIOperations
Supadelixir Co Ltd688481952manufacture(71200-405)

 
Supadelixir Co Ltd

Medically reviewed on Feb 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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