SERUM X- lidocaine hydrochloride gel

Serum X by

Drug Labeling and Warnings

Serum X by is a Otc medication manufactured, distributed, or labeled by AO Biologix, LLC, TRI-PAC, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine Hydrochloride 0.5%

Purpose

Lidocaine Hydrochloride 0.5%...............Topical Analgesic

Uses

For the temporary relief of pain

Warnings

For external use only

Do not use

• in large quantities, particularly over raw surfaces or blistered areas

When using this product

• avoid contact with the eyes

Stop use and ask doctor if

• condition worsens
• any allergic reaction occurs
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Keep out of the reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor

Other information

• store in a cool, dry place away from light
• this package is child-resistant

Inactive ingredients

Water, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben

Questions or comments?

Call 855-910-1252 Monday-Friday; 9am-5pm MST.

SerumX.com

PRINCIPAL DISPLAY PANEL

AO Biologix

Serum X

Pain Relief Gel

Fast Acting Lidocaine

With Antioxidant Properties

30mL/1 Fl. oz.

INGREDIENTS AND APPEARANCE

SERUM X 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82317-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM PHOSPHATE (UNII: SE337SVY37)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82317-001-30	1 in 1 CARTON	04/21/2022
1		30 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 82317-001-01	1 in 1 PACKAGE	07/01/2022
2		0.5 g in 1 PACKET; 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	04/21/2022

Labeler - AO Biologix, LLC (102188692)

Establishment
Name	Address	ID/FEI	Business Operations
TRI-PAC, INC.		020844956	manufacture(82317-001)