BIOSCRIPTIVES LIDUM - lidocaine hydrochloride cream 
BioChemics, Inc

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Active Ingredients
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 to externally to affected areas 3-4 times a day.

Inactive Ingredients:  AloeVera 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

BIOSCRIPTIVES  LIDUM lidocaine   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 17.92 g  in 56 g Water 12.37 g  in 56 g Cholesterol 5.60 g  in 56 g Isopropyl Myristate 4.48 g  in 56 g CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 4.20 g  in 56 g GLYCERYL MONOSTEARATE 1.4 g  in 56 g ARGININE HYDROCHLORIDE 1.23 g  in 56 g Propylene Glycol 1.12 g  in 56 g Ethyl Oleate 1.12 g  in 56 g TOCOPHERSOLAN 1.12 g  in 56 g CETYL ALCOHOL 1.12 g  in 56 g XANTHAN GUM .56 g  in 56 g TROLAMINE .56 g  in 56 g ALLANTOIN .14 g  in 56 g ALPHA-TOCOPHEROL .14 g  in 56 g ALOE VERA LEAF .06 g  in 56 g METHYLISOTHIAZOLINONE .06 g  in 56 g METHYL NICOTINATE .01 g  in 56 g LECITHIN, SOYBEAN 1.4 g  in 56 g MEDIUM-CHAIN TRIGLYCERIDES 1.4 g  in 56 g PROPYLENE GLYCOL 1.4 g  in 56 g

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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)

Establishment
Name	Address	ID/FEI	Operations
Coastal Products Company		782445688	manufacture

Revised: 10/2010BioChemics, Inc