XEROBURN BURN GEL- lidocaine hydrochloride gel 
Dynarex Corporation

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.

----------

1290 XeroBurn Burn Gel 67777-129-00
1291 XeroBurn Burn Gel 67777-129-01
1292 XeroBurn Burn Gel 67777-129-02

Active Ingredient

Lidocaine Hydrochloride 2%

Purpose

Analgesic

Use(s)

■ For the temporary relief of pain associated with ■ Minor burns ■ Sunburn

■ Provides cooling pain relief

Warnings

For External Use Only

Do not use

■ On wounds or damaged skin

■ In large quantities, particularly over raw surfaces or blistered areas

When using this product

■ Avoid contact with the eyes

■ Do not bandage tightly

Stop use and ask a doctor if

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 at room temperature 15º-30ºC (59º-86ºF)

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

Questions?

1-888-396-2739 Monday - Friday, 9AM - 5PM EST

Label

1291 BX MASTER (R170629-3)

XEROBURN BURN GEL 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
IMIDUREA (UNII: M629807ATL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-129-10600 in 1 CASE09/07/2017
1NDC:67777-129-016 in 1 BOX
13.5 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:67777-129-09600 in 1 CASE09/07/2017
2NDC:67777-129-0025 in 1 BOX
23.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:67777-129-021728 in 1 CASE09/07/2017
33.5 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 finalpart34809/07/2017
Labeler - Dynarex Corporation (008124539)

Revised: 1/2023
Document Id: f2919622-621f-1477-e053-2995a90abd5c
Set id: 58985046-ca9c-12be-e053-2991aa0abe72
Version: 5
Effective Time: 20230118
 
Dynarex Corporation