BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL)- lidocaine cream

Bio-Scriptives Lidum Hemorroidal (Anorectal) by

Drug Labeling and Warnings

Bio-Scriptives Lidum Hemorroidal (Anorectal) by is a Otc medication manufactured, distributed, or labeled by Bio-Scriptives, Inc., Coastal Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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INGREDIENTS AND APPEARANCE

BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL) 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60608-016
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: 60608-016-01	1 in 1 BOX
1	NDC: 60608-016-00	56 g in 1 TUBE
2	NDC: 60608-016-03	15 in 1 BOX
2	NDC: 60608-016-02	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	03/04/2012

Labeler - Bio-Scriptives, Inc. (802946426)

Establishment
Name	Address	ID/FEI	Business Operations
Coastal Products Company		782445688	manufacture(60608-016)