Pomg Night Time Pain Relief Roller

Pomg Night Time Pain Relief Roller
SPL v3
SPL
SPL Set ID 28d7dfb0-a94c-90de-e063-6294a90a036a
Route
TOPICAL
Published
Effective Date 2024-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Barbadensis Leaf Magnesium Chloride Withania Somnifera Root Theanine Water Hydroxypropyl Starch Reishi

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-06

Description

Lidocaine HCl 4%

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic


Medication Information

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic

Description

Lidocaine HCl 4%

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 51945-4

Lidocaine 4%

NDC: 84615-007-02

P.O.M.G.

Pharmaceutical Organic Medicine Group

Night Time Pain Relief Roller

Maximum Strength Lidocaine Without a Prescription

No Melatonin

Promotes Relaxation

Relieves Aches & Pains

Made with Organic Ingredients

Net Wt. 2 Oz (59mL)

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 before bedtime

• Children under 12 years of age: consult a doctor

• Wash hands after use with soap and water

Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients

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


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 51945-4 (51945-4)

Lidocaine 4%

NDC: 84615-007-02

P.O.M.G.

Pharmaceutical Organic Medicine Group

Night Time Pain Relief Roller

Maximum Strength Lidocaine Without a Prescription

No Melatonin

Promotes Relaxation

Relieves Aches & Pains

Made with Organic Ingredients

Net Wt. 2 Oz (59mL)

Section 53414-9 (53414-9)

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

Purpose

Lidocaine HCl 4% ……….…Topical Anesthetic

Warnings

For external use only

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

Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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