PAIN-X by OL PHARMA TECH,LLC / OL PHARMA TECH,LLC (Drs. Pharmacy) PAIN-X- menthol gel

PAIN-X by

Drug Labeling and Warnings

PAIN-X by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH,LLC, OL PHARMA TECH,LLC (Drs. Pharmacy). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 2.5%

Purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backaches
• arthritis
• strains
• bruises
• sprains

Warnings

for external use only

Do not use

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use

Ask a doctor before use

Ask a doctor before use if you have redness over the affected area.

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other information

• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

Vitamin E, Propylene glycol,Polysorbate 80,Water, Isopropyl alcohol,Carbomer interpolymer typ A, edta, Methylparaben, Propylparaben.

Questions

www.drspharmacyusa.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN-X 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (TRANSLUCENT)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-003-01	1 in 1 CARTON	01/01/2021
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 80489-003-02	1 in 1 CARTON	01/01/2021
2		49.6 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2021

Labeler - OL PHARMA TECH,LLC (021170377)

Registrant - OL PHARMA TECH,LLC (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH,LLC (Drs. Pharmacy)		021170377	manufacture(80489-003)