POMG NIGHT TIME PAIN RELIEF ROLLER- lidocaine hydrochloride gel

POMG NIGHT TIME PAIN RELIEF ROLLER by

Drug Labeling and Warnings

POMG NIGHT TIME 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%

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic

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 before bedtime

Children under 12 years of age: consult a doctor

Wash hands after use with soap and water

Inactive Ingredients

Water, organic aloe juice, magnesium chloride flakes, hydroxypropyl starch phosphate, organic ashwaghanda root, l-theanine, reishi mushroom

PRINCIPAL DISPLAY PANEL

Lidocaine 4%

NDC: 84615-007-02

P.O.M.G.

Pharmaceutical Organic Medicine Group

Night Time Pain Relief Roller

Recommended by physicians everywhere

Maximum Strength Lidocaine Without a Prescription

No Melatonin

Promotes Relaxation

Relieves Aches & Pains

Net Wt. 2 Oz (59mL)

INGREDIENTS AND APPEARANCE

POMG NIGHT TIME PAIN RELIEF ROLLER 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84615-007
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
THEANINE (UNII: 8021PR16QO)
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL STARCH (UNII: 9M44R3409A)
REISHI (UNII: TKD8LH0X2Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84615-007-02	1 in 1 CARTON	12/06/2024
1		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	12/06/2024

Labeler - POMG LLC (119126509)

Establishment
Name	Address	ID/FEI	Business Operations
POMG LLC		119126509	manufacture(84615-007)