Pomg Pain Relief Roller

Pomg Pain Relief Roller
SPL v6
SPL
SPL Set ID 1fa980fb-fc0e-fdd0-e063-6394a90adc13
Route
TOPICAL
Published
Effective Date 2024-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Arnica Montana Flower Hydroxypropyl Corn Starch (5% Substitution By Weight) Capsicum Magnesium Chloride Calendula Officinalis Flower Water Aloe Vera Leaf Dimethyl Sulfone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-14

Description

Lidocaine HCl 4% Menthol 5%

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic Menthol 5% ………………... Pain Relief


Medication Information

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic

Menthol 5% ………………... Pain Relief

Description

Lidocaine HCl 4% Menthol 5%

Use
  • For temporary relief of pain in muscles, joints, and tendons
Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

Do not use

• If you are allergic to any ingredients in this product

• On open sores and wounds

• In large quantities

Section 51727-6

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)

Section 51945-4

Menthol 5% Lidocaine 4%

NDC: 84615-004-03

P.O.M.G

Pharmaceutical Organic Medicine Group

Pain Relief Roller

Recommened by physicians everywhere

Maximum Strength Lidocaine

Without a Prescription

Made with Organic Ingredients

Quick Drying

Instantly Relieves Pain

Net Wt. 3 OZ (90mL)

Section 53414-9

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

Warnings

For external use only

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

Active Ingredients

Lidocaine HCl 4%

Menthol 5%


Structured Label Content

Use
  • For temporary relief of pain in muscles, joints, and tendons
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use

• If you are allergic to any ingredients in this product

• On open sores and wounds

• In large quantities

Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Menthol 5% Lidocaine 4%

NDC: 84615-004-03

P.O.M.G

Pharmaceutical Organic Medicine Group

Pain Relief Roller

Recommened by physicians everywhere

Maximum Strength Lidocaine

Without a Prescription

Made with Organic Ingredients

Quick Drying

Instantly Relieves Pain

Net Wt. 3 OZ (90mL)

Section 53414-9 (53414-9)

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

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic

Menthol 5% ………………... Pain Relief

Warnings

For external use only

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

Active Ingredients

Lidocaine HCl 4%

Menthol 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)