BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC- lidocaine cream

Bio-Scriptives Lidum Topical Analgesic by

Drug Labeling and Warnings

Bio-Scriptives Lidum Topical Analgesic by is a Prescription medication manufactured, distributed, or labeled by Bio-Scriptives, Inc., Coastal Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC 
lidocaine cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60608-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2.8 g  in 56 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60608-017-01	1 in 1 BOX
1	NDC: 60608-017-00	56 g in 1 TUBE
2	NDC: 60608-017-03	15 in 1 BOX
2	NDC: 60608-017-02	4.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/07/2012

Labeler - Bio-Scriptives, Inc. (802946426)

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