IMADA FOUR SEASONS SAFE ANALGESIC BALM- menthol oil
LUEN WAH HK MEDICINE 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.

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Drug Facts

Active Ingredients

Menthol 16%

Purpose

External Analgesic

Uses

Temporarily relieves minor aches, muscles and joint pains due to:

simple backache
arthritis
strains
sprains
bruises
neck
shoulder
stiff and sore muscles

Warnings

external use only
use only as directed

Do not use

on opened wounds
on damaged skin

When using this product

avoid contact with the eyes
do not bandage tighly

Stop use and ask a doctor if

a rash or irritation develops
condition worsens
symptoms persist for more than 7 days or clears up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use

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

Directions

adults and children 12 years and older, apply to affected area, and massage gently not more than 3-4 times daily
children under 12 years of age, consult a doctor before using

Other information

store at room temperature
close tightly after used

Inactive ingredients

peppermint oil, cassia oil, clove oil, cinnamon leaf oil, licorice

Imada_FSS_Oil_25mL2mL

IMADA FOUR SEASONS SAFE ANALGESIC BALM
menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63041-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PEPPERMINT OIL (UNII: AV092KU4JH)
PADANG CASSIA OIL (UNII: 0E15252LIW)
CLOVE OIL (UNII: 578389D6D0)
CINNAMON LEAF OIL (UNII: S92U8SQ71V)
LICORICE (UNII: 61ZBX54883)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63041-110-01	25 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/30/2014	06/30/2020
2	NDC:63041-110-02	2 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/30/2014	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/30/2014	06/30/2020

Labeler - LUEN WAH HK MEDICINE LTD (666091871)

Name	Address	ID/FEI	Business Operations
Establishment
LUEN WAH HK MEDICINE LTD		666091871	manufacture(63041-110)

Revised: 11/2019

Document Id: 21050594-cbb0-47d6-9d13-a2ddc2ae4989

Set id: 4b71aed7-6a4a-4a40-a04b-21b5cd4bdfbc

Version: 2

Effective Time: 20191121

LUEN WAH HK MEDICINE LTD