SERUM X- lidocaine hydrochloride gel 
AO Biologix, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Serum X Pain Relief Gel

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

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

AO Biologix

Serum X

Pain Relief Gel

Fast Acting Lidocaine

With Antioxidant Properties

30mL/1 Fl. oz.

1

2

SERUM X 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82317-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82317-001-301 in 1 CARTON04/21/2022
130 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:82317-001-011 in 1 PACKAGE07/01/2022
20.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/21/2022
Labeler - AO Biologix, LLC (102188692)
Establishment
NameAddressID/FEIBusiness Operations
TRI-PAC, INC.020844956manufacture(82317-001)

Revised: 4/2022
Document Id: e07b6268-6401-6849-e053-2a95a90a8b3e
Set id: e07b6268-6400-6849-e053-2a95a90a8b3e
Version: 1
Effective Time: 20220421
 
AO Biologix, LLC