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Name:Bio-scriptives Lidum
Manufacturer:Biochemics, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BIO-SCRIPTIVES LIDUM  - lidocaine hydrochloride cream 
BioChemics, 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 5%



Purpose

Topical Anesthetic

Uses

■  rapid onset
■  temporary relief of pain and itching due to
■  minor burns
■  skin irritations
■  scrapes
■  cuts
■  sunburn
■  insect bites

Warnings

For external use only.

Do Not Use

■  in or near eyes
■  in large quantities, particularly over raw surfaces or blistered areas

Stop use if

■  allergic reaction occurs
■  condition worses or does not improve within 7 days

Keep out of the reach of children.

Directions

■  adults and children 2 years and up apply externally to affected areas 3-4 times a day.

Inactive Ingredients

Aloe Vera Juice, Water, Cholesterol, lsopropyl Myristate, Aqua and Caprylic Capric Triglyceride and Propylene Glycol and Hydrogenated Phosphatitylcholine, Glyceryl Stearate and PEG-100 Stearate, Arginine HCI, Ethyl OLeate, Propylene Glycol, dAlpha-Tocopheryl Polyethylene Glycol-1000 Succinate, Cetyl Alcohol,  Triethanolamine, Xanthan Gum, Vitamin E, Allantoin, Aloe Vera Powder, Methylisothiazolinone, Methyl Nicotinate

Labels

LidumFront

LidumBack1

LidumBack2


BIO-SCRIPTIVES LIDUM 
lidocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60608-011
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 2.8 g  in 56 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
WATER  
CHOLESTEROL  
ISOPROPYL MYRISTATE  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
GLYCERYL MONOSTEARATE  
ARGININE HYDROCHLORIDE  
PROPYLENE GLYCOL  
ETHYL OLEATE  
TOCOPHERSOLAN  
CETYL ALCOHOL  
XANTHAN GUM  
TROLAMINE  
ALLANTOIN  
ALPHA-TOCOPHEROL  
METHYLISOTHIAZOLINONE  
METHYL NICOTINATE  
LECITHIN, SOYBEAN  
MEDIUM-CHAIN TRIGLYCERIDES  
PROPYLENE GLYCOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60608-011-00 56 g in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/23/2010

Labeler - BioChemics, Inc (802946426)

Revised: 06/2011 BioChemics, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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