Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH PRETAT- lidocaine hcl cream 
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 inredients

indications and usage

keep out of reach of children

active ingredient

purpose

warnings

package label

EXTRA STRENGTH PRETAT 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69804-002
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
BORIC ACID (H3BO3), COMPD. WITH 2,2',2''-NITRILOTRIS(ETHANOL) (1:3) (UNII: 43O5OP619T) 58 mg  in 1000 mg
GUAR GUM (UNII: E89I1637KE) 36 mg  in 1000 mg
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) 0.8 mg  in 1000 mg
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
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
CARBOMER 940 (UNII: 4Q93RCW27E) 22 mg  in 1000 mg
WITCH HAZEL (UNII: 101I4J0U34) 89 mg  in 1000 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69804-002-0256700 mg in 1 JAR; Type 0: Not a Combination Product11/20/2015
2NDC: 69804-002-03113400 mg in 1 JAR; Type 0: Not a Combination Product09/07/2015
3NDC: 69804-002-0528500 mg in 1 JAR; Type 0: Not a Combination Product11/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/08/2015
Labeler - Ridge Properties (029478762)
Establishment
NameAddressID/FEIBusiness Operations
Ridge properties029478762manufacture(69804-002)

Revised: 11/2017
 
Ridge Properties


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