LIDOCAINE HYDROCHLORIDE gel

Lidocaine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Lidocaine HCl 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 directly

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

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

Directions

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Other information

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

Inactive ingredients

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

Principal Display Panel - Pouch Label

FIRST AID ONLY®

Burn Gel

For Temporary
Pain Relief of
Minor Burns

NET WT 3.5g

Distributed by

© 2016 Acme United Corporation.

Fairfield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5000
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: 0924-5000-01	6 in 1 BOX	02/14/2013
1	NDC: 0924-5000-00	3.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5000-02	25 in 1 BOX	02/14/2013
2	NDC: 0924-5000-00	3.5 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	02/14/2013

Labeler - Acme United Corporation (001180207)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0924-5000)