Your browser does not support JavaScript! DUANE READE ALOE VERA PAIN RELIEVING (LIDOCAINE) GEL [DUANE READE INC.]
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DUANE READE ALOE VERA PAIN RELIEVING (lidocaine) gel
[DUANE READE INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredients

Lidocaine 0.50%
Menthol  0.10%

Purpose

Topical Analgesic

Uses

  • temporary relief of pain and itching
  • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites.

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 if symptoms persists for more than 7 days.
  • symptoms clear up and occur again within a few days.

Keep out of the reach of children.

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

Directions

  • 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, ask a doctor.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Diazolidinyl urea, Disodium EDTA, Tocopherol, Blue 1.

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

aloe
vera

pain relieving gel
with Lidocaine and Menthol

NET WT 16 OZ (454 g)
ZDR011A0.jpg


DUANE READE ALOE VERA  PAIN RELIEVING
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-408
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE0.5 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
TROLAMINE 
TOCOPHEROL 
EDETATE DISODIUM 
ALOE VERA LEAF 
PROPYLENE GLYCOL 
GLYCERIN 
POLYSORBATE 20 
DIAZOLIDINYL UREA 
Packaging
#Item CodePackage Description
1NDC:67732-408-19454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/23/2012
Labeler - DUANE READE INC. (011988995)

Revised: 11/2012
Document Id: aa20220f-7ae0-48dd-b564-df9600fc6012
Set id: d227f447-e129-4c34-8300-d00580e61daa
Version: 1
Effective Time: 20121114
 
DUANE READE INC.

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