PO SUM ON HEALING BALM- menthol ointment

PO SUM ON HEALING BALM by

Drug Labeling and Warnings

PO SUM ON HEALING BALM 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 13%

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, Beeswax, Cinnamon Oil, Dragon's Blood (Xue-Jie) Resin, Licorice (Gan-Zao) Root, Peppermint Oil, Petrolatum, Stearic Acid, Tea Oil and White Paraffin Wax.

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 HEALING BALM

NDC: 54155-053-03

0.35 oz (10g)

INGREDIENTS AND APPEARANCE

PO SUM ON HEALING BALM 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54155-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
YELLOW WAX (UNII: 2ZA36H0S2V)
CINNAMON OIL (UNII: E5GY4I6YCZ)
DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU)
GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAMELLIA OIL (UNII: T1PE06G0VE)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54155-053-02	1 in 1 BOX	05/25/2017
1		18 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 54155-053-03	1 in 1 BOX	05/25/2017
2		10 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 54155-053-01	1 in 1 PACKET	08/22/2019
3		3.5 g in 1 JAR; 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	05/25/2017

Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395)

Establishment
Name	Address	ID/FEI	Business Operations
PO SUM ON MEDICINE FACTORY LIMITED		664986395	manufacture(54155-053)