DUANE READE BURN RELIEF PAIN RELIEVING GEL- lidocaine hydrochloride gel 
DUANE READE 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 Ingredient

Lidocaine HCl 0.50%

Purpose

Topical Anesthetic

Uses

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product

  • avoid contact with eyes.

stop use and ask a doctor if

  • Conditions worsens or symptoms persists for more than 7 days.
  • Symptoms clear up and occur 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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Diazolidinyl urea, Disodium EDTA, Menthol, Yellow 5, Blue 1.

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

burn
relief
pain relieving gel
with Lidocaine
NET WT 8 OZ (227 g)
ZDR008A0.jpg


DUANE READE BURN RELIEF  PAIN RELIEVING GEL
lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67732-406
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67732-406-16 226 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/13/2012
Labeler - DUANE READE INC. (011988995)

Revised: 10/2012
Document Id: 83de906c-fd8e-475a-8019-f10d83b661cd
Set id: f308f25c-9dd2-4445-9b50-f702511928dc
Version: 1
Effective Time: 20121023
 
DUANE READE INC.