BIO-SCRIPTIVES LIDUM - lidocaine 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

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BIO-SCRIPTIVES LIDUM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride2.8 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYL OLEATE (UNII: Z2Z439864Y)  
TOCOPHERSOLAN (UNII: O03S90U1F2)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALLANTOIN (UNII: 344S277G0Z)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60608-011-0056 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/23/2010
Labeler - BioChemics, Inc (802946426)

Revised: 6/2011
Document Id: 206bc7b7-5a2a-4e00-9dc2-3ca2c7b681c2
Set id: a383efb7-92fa-49a4-a436-af3e22d54acf
Version: 6
Effective Time: 20110603
 
BioChemics, Inc