PO SUM ON MEDICATED- menthol oil
PO SUM ON MEDICINE FACTORY LIMITED

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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Drug Facts

Active ingredients
Menthol 15%

Purpose
External analgesic

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

Warnings
For external use only

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

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

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.
If swallowed, get medical help or contact a Poison Control Center right away.

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

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

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

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

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

PO SUM ON MEDICATED
menthol oil

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/10/2004

Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395)

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

Revised: 11/2019

Document Id: 77df207f-5f49-4ce4-b9b9-b70cae25a872

Set id: 7239a241-afbf-4877-8608-59dff8d16187

Version: 3

Effective Time: 20191113

PO SUM ON MEDICINE FACTORY LIMITED