TIDL PAIN RELIEF HEAT THERAPY ROLL-ON- pain relief heat therapy roll-on gel

TIDL PAIN RELIEF HEAT THERAPY ROLL-ON by

Drug Labeling and Warnings

TIDL PAIN RELIEF HEAT THERAPY ROLL-ON by is a Otc medication manufactured, distributed, or labeled by Shenzhen Sam Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%
Menthol 1%

Purpose

Topical Anesthetic
Topical Analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only

Do not use

do not use wiih heating pad or device

When Using

·avoid contact with the eyes or mucous membranes
·do not apply to wounds or damaged skin
·do not apply to irritated skin
·do not bandage
·wash hands after use with cool water
·do not use with heating pad or device
·spray product away from nose,eyes,and mouth
·do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Keep Oot Of Reach Of Children

If accidentally ingested, get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use. If pregnant or breast-feeding, ask a healthcare professional before use.

Directions

·Adults and children 12 years of age and older：Apply to affected area not more than 3 to 4 times daily
·Children under 12 years of age：Consult physician

Inactive ingredients

Borneol, Carbohydrates, Ginger Extract, Mugwort Leaf Extract, Saffron Extract, Vanillyl butyl, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIDL PAIN RELIEF HEAT THERAPY ROLL-ON 
pain relief heat therapy roll-on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84214-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
BORNEOL (UNII: M89NIB437X)
CROCUS SATIVUS FLOWER (UNII: 00IF91KFKQ)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
GALECTIN-3 (UNII: VB5832VP5D)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84214-002-01	85 g in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/12/2024

Labeler - Shenzhen Sam Technology Co., Ltd. (418511877)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Sam Technology Co., Ltd.		418511877	manufacture(84214-002)