EXTRA STRENGTH PRETAT (LIDOCAINE HCL) GEL [RIDGE PROPERTIES]

EXTRA STRENGTH PRETAT (LIDOCAINE HCL) GEL [RIDGE PROPERTIES]
PDF | XML

NDC	69804-018-10, 69804-018-11, 69804-018-12
Set ID	39bd37bf-1fb7-6822-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Ridge Properties
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

View All Sections

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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PRETAT
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-018
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
WATER (UNII: 059QF0KO0R)	40 mg in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N)	180 mg in 1000 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	689 mg in 1000 mg
BENZYL ALCOHOL (UNII: LKG8494WBH)	10 mg in 1000 mg
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	30 mg in 1000 mg
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)	11 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69804-018-10	28350 mg in 1 JAR; Type 0: Not a Combination Product	08/17/2016
2	NDC:69804-018-11	56699 mg in 1 JAR; Type 0: Not a Combination Product	08/17/2016
3	NDC:69804-018-12	113398 mg in 1 JAR; Type 0: Not a Combination Product	08/17/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/17/2016

Labeler - Ridge Properties (029478762)

Name	Address	ID/FEI	Business Operations
Establishment
Ridge Properties		029478762	manufacture(69804-018)

View All Sections

Related Drugs