BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC- lidocaine cream 
Bio-Scriptives, 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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Bio-Scriptives Lidum (Lidocaine 4%) Topical Analgesic

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Local Analgesic

Uses

For the temporary relief of pain and itching due to:

■ minor burns

■ minor skin irritations

■ scrapes

■ minor cuts

■ sunburn

■ insect bites

Warnings

For external use only

When using this product

■ avoid contact with the eyes

■ do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if:

■ condition worsens

■ symptoms persist 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

■ Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: Consult a doctor.

Inactive Ingredients

Aloe, Water, Cholesterol, Isopropyl Myristate, Aqua Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCL, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate.

Package and Label Images

Lidum 4 Label

Lidum 4 Box

Lidum 4 Unit Pak Label

Lidum 4 Unit Pak Box

BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC 
lidocaine cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60608-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.8 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
ETHYL OLEATE (UNII: Z2Z439864Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TOCOPHERSOLAN (UNII: O03S90U1F2)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
xanthan gum (UNII: TTV12P4NEE)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALLANTOIN (UNII: 344S277G0Z)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60608-017-011 in 1 BOX
1NDC:60608-017-0056 g in 1 TUBE
2NDC:60608-017-0315 in 1 BOX
2NDC:60608-017-024.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/07/2012
Labeler - Bio-Scriptives, Inc. (802946426)
Establishment
NameAddressID/FEIBusiness Operations
Coastal Products Company782445688manufacture

Revised: 3/2012
Document Id: fa228065-45fa-40fe-8057-18c69a1b8394
Set id: a19bb9cc-b20b-4a15-9c82-dd2544cb252d
Version: 2
Effective Time: 20120309
 
Bio-Scriptives, Inc.