PAIN RELIEF GEL-ROLL ON- lidocaine and menthol gel

Pain Relief Gel-Roll On by

Drug Labeling and Warnings

Pain Relief Gel-Roll On by is a Otc medication manufactured, distributed, or labeled by Bullet point LLC, Bullet Point LLC, ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

PURPOSE

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

WARNINGS

Warnings

For external use only

INDICATIONS & USAGE

Use

Temporary relief of pain

Do not use

On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged skin on puncture wounds for more than one week without consulting a doctor.

When using this product

Use only as directed. Read and follow all directions and warnings on this label

Do not allow contact with eyes and mucous membranes

Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use

Do not use at the same time as other topical analgesics

Stop use if

Condition worsens

Redness is present

Irritation develops

Symptoms persist for more than 7 days or clear up and occur within a few days

ASK DOCTOR

Ask a doctor if

Condition worsens

Redness is present

Irritation develops

Symptoms persist for more than 7 days or clear up and occur within a few days

WARNINGS AND PRECAUTIONS

Flammable

Keep away from fire or flame

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding

• Ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed, get medical help or contact the Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and over:

• Apply a thin layer to the affected area for 6 to 8 hours
• Not to exceed 3 applications in a 24 hour period

Children under 12 years old: Consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients
Aloe Vera Extract, Carbomer, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

OTHER SAFETY INFORMATION

Child-resistant packaging. Close the cap tightly after use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL-ROLL ON 
lidocaine and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84008-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84008-002-02	1 in 1 BOX	11/03/2025
1	NDC: 84008-002-01	73 mL in 1 BOTTLE; 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	11/03/2025

Labeler - Bullet point LLC (118190100)

Registrant - Bullet Point LLC (118190100)

Establishment
Name	Address	ID/FEI	Business Operations
ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.		546872672	manufacture(84008-002) , label(84008-002)