LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride gel 
Dealmed Medical Supplies 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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Drug Facts

Active ingredient

Lidocaine HCI (2%)

Purpose

Topical Pain Relief

Uses

Temporary pain relief of minor burns. For professional use only.

Warnings

For external use only.

Keep out of reach of children

If ingested, get medical help or contact a Poison Control Center right away.

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens, rinse thoroughly with water

Stop use and ask a doctor if

  • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Other information

Inactive ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Questions or Comments?

1-800-456-7077

Principal Display Panel - 0.9g Box Label

NDC 70082-500-01

dealmed

Burn
Gel

For temporary relief
of minor burns

144
PACKETS

NET WT. 0.9g
PER PACKET

Principal Display Panel - 0.9g Box Label

Principal Display Panel - 0.9g Pouch Label

dealmed

Burn Gel

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com

Principal Display Panel - 0.9g Pouch Label
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70082-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
menthol (UNII: L7T10EIP3A)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70082-500-01144 in 1 BOX03/18/2022
10.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/18/2022
Labeler - Dealmed Medical Supplies LLC (068586441)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(70082-500)

Revised: 3/2022
Document Id: dfd6261a-3c16-426e-b595-aea1573fb290
Set id: 9f02911b-b0be-454a-8889-8307592b6aed
Version: 1
Effective Time: 20220308
 
Dealmed Medical Supplies LLC