EXTRA STRENGTH PRETAT- lidocaine hcl gel

Extra Strength PreTAT by

Drug Labeling and Warnings

Extra Strength PreTAT by is a Otc medication manufactured, distributed, or labeled by ridge properties, Ridge Properties. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 69804-019
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CASHEW OIL (UNII: PI97M87E46)	22 mg  in 1000 mg
NUTMEG OIL (UNII: Z1CLM48948)	133 mg  in 1000 mg
ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43)	133 mg  in 1000 mg
BANANA (UNII: 4AJZ4765R9)	22 mg  in 1000 mg
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)	107 mg  in 1000 mg
CARBOMER 940 (UNII: 4Q93RCW27E)	13 mg  in 1000 mg
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W)	307 mg  in 1000 mg
BORIC ACID (H3BO3), COMPD. WITH 2,2',2''-NITRILOTRIS(ETHANOL) (1:3) (UNII: 43O5OP619T)	45 mg  in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N)	89 mg  in 1000 mg
WITCH HAZEL (UNII: 101I4J0U34)	89 mg  in 1000 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/17/2016

Labeler - ridge properties (029478762)

Establishment
Name	Address	ID/FEI	Business Operations
Ridge Properties		029478762	manufacture(69804-019)