PO SUM ON MEDICATED- menthol oil

PO SUM ON MEDICATED by

Drug Labeling and Warnings

PO SUM ON MEDICATED by is a Otc medication manufactured, distributed, or labeled by PO SUM ON MEDICINE FACTORY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Menthol 15%

PURPOSE

Purpose
External analgesic

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
bruises
sprains

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use
on wounds
on damaged skin
if excessive irritation develops

WHEN USING

When using this product
avoid contact with the eyes
do not bandage tightly

STOP USE

Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
when using for pain of arthritis if:
pain persists for more than 10 days
redness is present
in conditions affecting children under 12 years of age

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult your doctor

STORAGE AND HANDLING

Other information
keep container tightly closed
store at 15∫ to 30C (59 to 86F)

INACTIVE INGREDIENT

Inactive ingredients
BaikaL Skullcap (Huang-Qin) Root, Chinese Licorice (Gan-Zao) Root, Cinnamon Oil, Dragon’s Blood (Xue-Jie) Resin, Peppermint Oil, and Tea Oil.

QUESTIONS

Questions or comments? (888)221-3496 M-F 9am to 5pm
you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

PO SUM ON MEDICATED OIL, EXTERNAL ANALGESIC, NDC: 54155-052-01 Net wt. 1 fl. oz (30ml.)

PO SUM ON MEDICATED OIL, EXTERNAL ANALGESIC, NDC: 54155-052-02, FREE SAMPLE, NOT FOR RESALE, 0.19 fl. oz (5.6 ML)

INGREDIENTS AND APPEARANCE

PO SUM ON MEDICATED 
menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54155-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)
CINNAMON OIL (UNII: E5GY4I6YCZ)
DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU)
PEPPERMINT OIL (UNII: AV092KU4JH)
CAMELLIA OIL (UNII: T1PE06G0VE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54155-052-01	1 in 1 CAN	05/10/2004
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 54155-052-02	1 in 1 BOX	05/10/2004
2		5.6 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/10/2004

Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395)

Establishment
Name	Address	ID/FEI	Business Operations
PO SUM ON MEDICINE FACTORY LIMITED		664986395	manufacture(54155-052)