TOPICAL ANALGESIC GEL- menthol, camphor gel

Topical Analgesic Gel by

Drug Labeling and Warnings

Topical Analgesic Gel by is a Otc medication manufactured, distributed, or labeled by Supadelixir Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

TOPICAL ANALGESIC GEL 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71200-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PALMITOYL SH-TRIPEPTIDE-4 AMIDE (UNII: 95R2G78A7J)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71200-405-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/02/2017

Labeler - Supadelixir Co Ltd (688481952)

Establishment
Name	Address	ID/FEI	Business Operations
Supadelixir Co Ltd		688481952	manufacture(71200-405)