POMG PAIN RELIEF ROLLER- lidocaine hydrochloride, menthol gel

POMG PAIN RELIEF ROLLER by

Drug Labeling and Warnings

POMG PAIN RELIEF ROLLER by is a Otc medication manufactured, distributed, or labeled by POMG LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCl 4%

Menthol 5%

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic

Menthol 5% ………………... Pain Relief

Use

• For temporary relief of pain in muscles, joints, and tendons

Warnings

For external use only

Do not use

If you are allergic to any ingredients in this product

On open sores and wounds

In large quantities

When using this product

Use only as directed

Do not bandage tightly

Avoid contact with eyes and other mucous membranes

Do not expose the area to external heat or direct sunlight

Stop use and consult a doctor if

Conditions worsen or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Redness is present or excessive skin irritation occurs

You experience severe burning pain, swelling, or blistering where product was applied

Allergic reaction occurs

If pregnant or breast-feeding, consult a doctor before use

Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away

Directions

Adults and children 12 years of age and older:

rub a thin film over desired area not more than 3 to 4 times daily

Children under 12 years of age: consult a doctor

Wash hands after use with soap and water

INACTIVE INGREDIENT

reverse osmosis water, organic aloe juice, magnesium chloride flakes, msm (methylsulfonylmethane), hydroxypropyl starch phosphate, organic arnica (co2 extract), organic calendula (co2 extract), organic capsicum (co2 extract)

PRINCIPAL DISPLAY PANEL

Menthol 5% Lidocaine 4%

P.O.M.G

Pharmaceutical Organic Medicine Group

Pain Relief Roller

Maximum Strength Lidocaine

Without a Prescription

Made with Organic Ingredients

Quick Drying

Instantly Relieves Pain

Net Wt. 3 OZ (90mL)

INGREDIENTS AND APPEARANCE

POMG PAIN RELIEF ROLLER 
lidocaine hydrochloride, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84615-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
PAPRIKA (UNII: X72Z47861V)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84615-004-03	90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/14/2024
2	NDC: 84615-004-02	1 in 1 CARTON	08/14/2024
2		59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/14/2024

Labeler - POMG LLC (119126509)

Establishment
Name	Address	ID/FEI	Business Operations
POMG LLC		119126509	manufacture(84615-004)