BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL)- 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 5%) Hemorroidal (Anorectal) Cream

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

■ For the temporary relief of local discomfort associated with anorectal disorders

■ For the temporary relief of pain, soreness, and burning.

Warnings

For external use only.

When using this product ■ do not exceed the recommended daily dosage unless directed by a doctor.

do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and consult a doctor if:

■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ allergic reaction occurs ■ redness, irritation, swelling, pain or other symptoms develop or increase

Keep out of reach of children.

Directions

■ Children under 12 years of age: consult a doctor. ■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.

Inactive Ingredients

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

Package and Lidum Images

Lidum 5 Label

Lidum 5 Box

Lidum 5 Unit Pak Label+

Lidum 5 Unit Pak Box

BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL) 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-016
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:60608-016-011 in 1 BOX
1NDC:60608-016-0056 g in 1 TUBE
2NDC:60608-016-0315 in 1 BOX
2NDC:60608-016-024.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/04/2012
Labeler - Bio-Scriptives, Inc. (802946426)
Establishment
NameAddressID/FEIBusiness Operations
Coastal Products Company782445688manufacture(60608-016)

Revised: 3/2012
Document Id: 25174fb2-87a8-4a29-96f8-e0fd452b5971
Set id: 3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f03
Version: 2
Effective Time: 20120309
 
Bio-Scriptives, Inc.