EXTRA STRENGTH PRETAT- lidocaine hcl gel
ridge properties

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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EXTRA STRENGTH PRETAT
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-019
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	20 mg in 1000 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	689 mg in 1000 mg
BENZYL ALCOHOL (UNII: LKG8494WBH)	10 mg in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N)	180 mg in 1000 mg
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)	11 mg in 1000 mg
WATER (UNII: 059QF0KO0R)	50 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69804-019-14	28350 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/17/2016
2	NDC:69804-019-15	56699 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/17/2016
3	NDC:69804-019-16	113398 mg in 1 BOTTLE, DISPENSING; 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(69804-019)