LIDOCAINE HYDROCHLORIDE gel

Lidocaine Hydrochloride by

Drug Labeling and Warnings

Lidocaine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Dealmed Medical Supplies LLC, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• for 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: do not use, consult a doctor

Other information

• store at room temperature (do not freeze)
• do not use any opened or torn packets

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 Pouch Label

dealmed

Burn Gel

0.9g (1/32 oz.)

Dealmed Brooklyn, NY

www.dealmed.com

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70082-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	18 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70082-500-01	144 in 1 BOX	03/18/2022
1		0.9 g in 1 POUCH; 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	03/18/2022

Labeler - Dealmed Medical Supplies LLC (068586441)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(70082-500)