Pain Relief Cream: Package Insert and Label Information

PAIN RELIEF CREAM- camphor (natural) 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 cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66653-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 1 g in 100 g

Inactive Ingredients Ingredient Name Strength SOPHORA FLAVESCENS ROOT MACLURA COCHINCHINENSIS ROOT LANOLIN MINERAL OIL ETHYLPARABEN ILEX PUBESCENS ROOT GLYCERIN TROLAMINE DIMETHYL SULFOXIDE ARALIA CHINENSIS WHOLE AMPELOPSIS GLANDULOSA VAR. BREVIPEDUNCULATA FRUIT PHERETIMA ASPERGILLUM PETROLATUM STEARIC ACID OLDENLANDIA DIFFUSA PINUS MASSONIANA LEAF DRYNARIA FORTUNEI ROOT ADINA RUBELLA WHOLE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66653-100-01 30 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/05/2016

Labeler — Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. (420823163)

Establishment
Name	Address	ID/FEI	Operations
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.		420823163	manufacture (66653-100)

Revised: 04/2016 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.