Pain Relief Cream: Package Insert and Label Information

PAIN RELIEF CREAM- camphor (natural) cream
Health Town Inc

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.

Camphor 1%

External Analgesic

Topical Analgesic

Pain relieving cream

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

-simple backache

-arthritis

-strains

-bruises

-spains

Children under 2 years of age: consult a doctor.

For extenal use only

Do not use:

-on wounds

-on irritated or damaged skin

-otherwise than as directed

When using this product:

-avoid contact with the eyes or mucous membranes

-do not bandage tightly

-adults and children 3 years of age and older: apply 3 or 4 drops of medicate oil to the affecte area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and ten massaged as shown in the illustrations.

-Children under 3 years of age, consult your physician

-refer to the above warning; otherwise than as directed may be dangerous

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

Pain Relief Cream
(click image for full-size original)

PAIN RELIEF CREAM
camphor cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70576-001
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
MINERAL OIL
ETHYLPARABEN
TROLAMINE
ILEX PUBESCENS ROOT
PHERETIMA ASPERGILLUM
STEARIC ACID
ARALIA CHINENSIS WHOLE
OLDENLANDIA DIFFUSA
PINUS MASSONIANA LEAF
AMPELOPSIS GLANDULOSA VAR. BREVIPEDUNCULATA FRUIT
GLYCERIN
DIMETHYL SULFOXIDE
LANOLIN
MACLURA COCHINCHINENSIS ROOT
PETROLATUM
SOPHORA FLAVESCENS ROOT
DRYNARIA FORTUNEI ROOT
ADINA RUBELLA ROOT
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70576-001-01 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 03/30/2016
Labeler — Health Town Inc (140637161)
Establishment
Name Address ID/FEI Operations
Zhejiang Apeloa Kangyu Natural Pharmaceutical Co., Ltd 420823163 manufacture (70576-001)

Revised: 03/2016 Health Town Inc

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