LIDOCAINE HYDROCHLORIDE gel

Lidocaine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Pain Relief

Drug Facts

Active Ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

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 doctor if condition worsens or persists for more than 7 days or clears up and occurs again within a few days

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away

Directions

• for adults and children 2 years and older: apply to affected area not more than 4 times daily
• children under 2: do not use, consult a doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

NDC: 61010-5000-0

Safetec

Burn Gel

For Temporary
Pain Relief of
Minor Burns

0.125 oz. (3.7 ml)
Reorder no. 50000

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

NDC: 61010-5000-1

Safetec

First Aid
Burn Gel

For Temporary
Pain Relief of
Minor Burns

4 fl. oz. (118 ml)
Reorder no. 50001

Principal Display Panel - Pouch label

Safetec

Burn Gel

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - 144 Box label

NDC: 61010-5000-04

Safetec

First Aid

Burn Gel

For Temporary Pain Relief
of Minor Burns

Reorder No. 50007

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - 25 Box label

NDC: 61010-5000-5

Safetec

First Aid

Burn Gel

For Temporary Pain Relief
of Minor Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel – 10 Packet Box Label

Safetec®

First Aid

Burn Gel

Quickly soothes pain
caused by minor burns

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 50028

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	20 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: 61010-5000-0	3.3 g in 1 PACKET; Type 0: Not a Combination Product	09/19/2012
2	NDC: 61010-5000-1	121.2 g in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2012
3	NDC: 61010-5000-3	0.9 g in 1 POUCH; Type 0: Not a Combination Product	09/19/2012
4	NDC: 61010-5000-4	144 in 1 CARTON	09/19/2012
4		0.9 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 61010-5000-5	25 in 1 CARTON	09/19/2012
5		0.9 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 61010-5000-6	10 in 1 BOX	04/01/2020
6		0.9 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	09/19/2012

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5000)