Bio-Scriptives Lidum Hemorroidal (Anorectal)

Dosage form: cream
Ingredients: LIDOCAINE 2.8g in 56g
Labeler: Bio-Scriptives, Inc.
NDC Code: 60608-016

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.

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

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BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL) 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE2.8 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
CHOLESTEROL 
ISOPROPYL MYRISTATE 
MEDIUM-CHAIN TRIGLYCERIDES 
HYDROGENATED SOYBEAN LECITHIN 
GLYCERYL MONOSTEARATE 
POLYETHYLENE GLYCOL 
ARGININE HYDROCHLORIDE 
ETHYL OLEATE 
PROPYLENE GLYCOL 
TOCOPHERSOLAN 
CETYL ALCOHOL 
TROLAMINE 
XANTHAN GUM 
ALPHA-TOCOPHEROL 
ALLANTOIN 
METHYLISOTHIAZOLINONE 
METHYL NICOTINATE 
Packaging
#Item CodePackage Description
1NDC:60608-016-011 TUBE in 1 BOX
1NDC:60608-016-0056 g in 1 TUBE
2NDC:60608-016-0315 TUBE 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/FEIOperations
Coastal Products Company782445688manufacture(60608-016)

Revised: 03/2012
 
Bio-Scriptives, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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