LIDOCOLL - lidocaine hcl spray
Innocoll Pharmaceuticals

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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Drug Facts

Lidocaine HCl 4%...............Anesthetic

Purpose

Anasthetic

Warning

Keep out of reach of children

Use

For the temporary relief of pain and
itching associated with minor burns,
sunburn, minor cuts, scrapes, insect
bites or minor skin irritations.

Warning

Avoid contact with eyes. If condition
worsens, or if symptoms persist for
more than 7 days or clear up and
occur again within a few days,
discontinue use and consult a doctor.
Keep out of reach of children.

Directions

Adults and children 2 years of age
and older: Apply Lidocoll spray not
more than 3 to 4 times per day or
moisten dressing prior to removal
to reduce pain.
Children under 2 years of age
consult a doctor.

Inactive Ingredients

hydrolyzed fish collagen (15%),
purified water, benzethonium
chloride and HCl.

LIDOCOLL
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51715-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride	4.6 g in 115 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Benzethonium Chloride (UNII: PH41D05744)	115 mg in 115 g
Hydrochloric Acid (UNII: QTT17582CB)	100 mg in 115 g
Fish (UNII: 1PIO77PW2X)	17.25 g in 115 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51715-001-01	115 g in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/2011

Labeler - Innocoll Pharmaceuticals (989921395)