EXTRA STRENGTH PRETAT (LIDOCAINE) LIQUID [RIDGE PROPERTIES]

EXTRA STRENGTH PRETAT (LIDOCAINE) LIQUID [RIDGE PROPERTIES]
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NDC	69804-001-01, 69804-001-04, 69804-001-07
Set ID	169f94d4-2b0f-0044-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	Ridge Properties
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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DOSAGE & ADMINISTRATION
KEEP OUT OF REACH OF CHILDREN
INDICATIONS & USAGE
INACTIVE INGREDIENT
ACTIVE INGREDIENT
PURPOSE
WARNINGS
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PRETAT
lidocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1000 mg

Ingredient Name	Strength
Inactive Ingredients
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)	11 mg in 1000 mg
WATER (UNII: 059QF0KO0R)	69 mg in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N)	180 mg in 1000 mg
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	1 mg in 1000 mg
BENZYL ALCOHOL (UNII: LKG8494WBH)	10 mg in 1000 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	689 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69804-001-01	56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/20/2015
2	NDC:69804-001-04	113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/07/2015
3	NDC:69804-001-07	28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/08/2015

Labeler - Ridge Properties (029478762)

Name	Address	ID/FEI	Business Operations
Establishment
Ridge Properties		029478762	manufacture(69804-001)

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