LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride liquid 
Afassco Inc.

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 Ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use

Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and returns

Keep out of reach of children.

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

Directions

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

PRINCIPAL DISPLAY PANEL – 2 oz. bottle

Burn
Spray
External Analgesic

#610 2 Fl. Oz. (59 mL)

Mfd. For
Afassco
MINDEN, NV 89423

PRINCIPAL DISPLAY PANEL – 2 oz. bottle
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-6101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride200 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-6101-20.059 L in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/16/2012
Labeler - Afassco Inc. (609982723)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(51532-6101)

Revised: 7/2012
Document Id: aada473d-23f5-4eca-8611-d1d0bf745e7a
Set id: 3dfb4c70-1bbf-4c77-9d8d-e135dbea15d2
Version: 2
Effective Time: 20120731
 
Afassco Inc.