PAIN RELIEF CREAM- pain relief cream cream 
Zhejiang Apeloa Kangyu Pharmaceutical 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.

----------

-External Analgesic

-Topical Analgesic

-Pain relieving cream

Children under 2 years of age: consult a doctor

Temporarily relieves minor aches and pains of muscles and joints associated with:

-simple backache

-arthritis

-strains

-bruises

-sprains

Do Not Use:

-on wounds

-on irritated or damaged skin

-otherwise than as directed

Adults and children 3 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After appling the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.

-Yellow Vaseline

-Wool Grease

-Liquid Paraffin

-Stearic Acid

-Glycerol

-Triethanolamine

-Ethylparaben

-Dimethyl Sulfoxide

-Radix Illcis Pubescentis

-Cortex Araliae

-Pheretima

-Herba Hedyotis Chrysotricae

-Radix Pini Massonianae

-Sophorae Flavescentis Radix

-Drynariae Rhizoma

-Radix Adinae Rubellae

-Radix Cudraniae Cochinchinensis

-Root from Itea Oblonga Hand.-Mazz

-Root from Syzygium Grijsii (Hance) Merr.Et

-Perry & Root from Ampelopsis Sinica (MIQ) W.T. Wang & Root from Ormosia Henryi Prain & Cuscuta Japonica Choisy

Camphor 1%

Pain Relief Cream

PAIN RELIEF CREAM 
pain relief cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66653-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
MACLURA COCHINCHINENSIS ROOT (UNII: 3WTU9E1VPU)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
ETHYLPARABEN (UNII: 14255EXE39)  
ILEX PUBESCENS ROOT (UNII: V5V22LFX73)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ARALIA CHINENSIS WHOLE (UNII: 4048809221)  
AMPELOPSIS GLANDULOSA VAR. BREVIPEDUNCULATA FRUIT (UNII: Y6SZ1HB5NG)  
PHERETIMA ASPERGILLUM (UNII: 1842H27PGA)  
PETROLATUM (UNII: 4T6H12BN9U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
OLDENLANDIA DIFFUSA (UNII: 291PPU5K9I)  
PINUS MASSONIANA LEAF (UNII: OFD5T4515T)  
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
ADINA RUBELLA WHOLE (UNII: 1S210XS3BZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66653-100-0130 g in 1 TUBE; Type 0: Not a Combination Product04/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2016
Labeler - Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. (420823163)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.420823163manufacture(66653-100)

Revised: 4/2016
Document Id: 2fe57dca-9611-6f20-e054-00144ff8d46c
Set id: 2fbfc4ac-75a5-6e28-e054-00144ff8d46c
Version: 3
Effective Time: 20160405
 
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.