Drug Labeling and Warnings

Drug Details

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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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dosage and administration

inactive ingredients

indications and usage

keep out of reach of children

active ingredients

purpose

warnings

package label

EXTRA STRENGTH PRETAT 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69804-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
BANANA (UNII: 4AJZ4765R9) 22 mg  in 1000 mg
CASHEW OIL (UNII: PI97M87E46) 22 mg  in 1000 mg
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 285 mg  in 1000 mg
WITCH HAZEL (UNII: 101I4J0U34) 89 mg  in 1000 mg
NUTMEG OIL (UNII: Z1CLM48948) 133 mg  in 1000 mg
ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 133 mg  in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N) 89 mg  in 1000 mg
BORIC ACID (H3BO3), COMPD. WITH 2,2',2''-NITRILOTRIS(ETHANOL) (1:3) (UNII: 43O5OP619T) 58 mg  in 1000 mg
CARBOMER 940 (UNII: 4Q93RCW27E) 22 mg  in 1000 mg
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) 107 mg  in 1000 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69804-018-1028350 mg in 1 JAR; Type 0: Not a Combination Product08/17/2016
2NDC: 69804-018-1156699 mg in 1 JAR; Type 0: Not a Combination Product08/17/2016
3NDC: 69804-018-12113398 mg in 1 JAR; Type 0: Not a Combination Product08/17/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/17/2016
Labeler - Ridge Properties (029478762)
Establishment
NameAddressID/FEIBusiness Operations
Ridge Properties029478762manufacture(69804-018)

Revised: 11/2017
 
Ridge Properties


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