IMADA FOUR SEASONS SAFE ANALGESIC BALM- menthol oil

IMADA FOUR SEASONS SAFE ANALGESIC BALM by

Drug Labeling and Warnings

IMADA FOUR SEASONS SAFE ANALGESIC BALM by is a Otc medication manufactured, distributed, or labeled by LUEN WAH HK MEDICINE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Drug Facts

Active Ingredients

Menthol 16%

PURPOSE

​Purpose

​External Analgesic

INDICATIONS & USAGE

​Uses

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

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

WARNINGS

​Warnings

• ​external use only
• use only as directed

DO NOT USE

​Do not use

• ​on opened wounds
• on damaged skin

WHEN USING

​When using this product

• ​avoid contact with the eyes
• do not bandage tighly

STOP USE

​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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

​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 SAFETY INFORMATION

​Other information

• ​store at room temperature
• close tightly after used

INACTIVE INGREDIENT

​ ​Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/30/2014	06/30/2020

Labeler - LUEN WAH HK MEDICINE LTD (666091871)

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