SELDICINE (MASSAGE CREAM)- camphor, menthol cream 
Orye Life Science Co., 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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Seldicine (Massage Cream)

Active Ingredients

Camphor 1%
Menthol 1%

Purpose

Topical Analgesic

Keep out of reach of children

Uses

For the temporary relief of minor aches and pains of muscles and joints

Warnings

Do not use if you have red rash, swell, itch or any other abnormal physical symptoms while applying it on your body parts
Do not use on injured body parts, eczema or dermatitis
Keep it at a room temperature and out of children’s reach
Be careful not to get in your eyes

Dossage

Apply on body parts, for arms or legs, apply on both sides together and you have better thermo-therapeutical effect

Inactive Ingredients

Ledum Palustre Extract, Angelica Gigas Extract, Cnidium Officinale Root Extract, Sophora Augustifolia Root Extract, Glycyrrhiza Glabra Root Extract, Gradenia Florida Fruit Extract, Salvia Mittiorrhiza Flower Root Extract, Water, Steric Acid, Glycerin, Propylene Glycol, Carbomer, Polysorbate 80, Methylparaben, Phenoxyethanol, Propylparaben, Curcuma Louga Root Extract, Capsicum Annuum Fruit Extract, Artemisia Vulgaris Extract.

Product label

image description

SELDICINE (MASSAGE CREAM) 
camphor, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69083-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P)  
ANGELICA GIGAS ROOT OIL (UNII: 3EYY3K7TBB)  
CNIDIUM OFFICINALE ROOT OIL (UNII: 18602BEQ40)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0)  
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69083-101-01100 g in 1 TUBE; Type 0: Not a Combination Product01/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/07/2014
Labeler - Orye Life Science Co., Ltd. (688546629)
Establishment
NameAddressID/FEIBusiness Operations
Orye Life Science Co., Ltd.688546629manufacture(69083-101)

Revised: 1/2020
Document Id: 9c4f51da-ef42-2806-e053-2a95a90a61b4
Set id: 547c2c5c-886a-4949-b7ae-49c457f6b9db
Version: 3
Effective Time: 20200116
 
Orye Life Science Co., Ltd.