Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH PRETAT- lidocaine liquid 
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

keep out of reach of children

indications and usage

Inactive ingredients

Active ingredient

purpose

warnings

package label

EXTRA STRENGTH PRETAT 
lidocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69804-001
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
ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 133 mg  in 1000 mg
BANANA (UNII: 4AJZ4765R9) 20 mg  in 1000 mg
CASHEW OIL (UNII: PI97M87E46) 25 mg  in 1000 mg
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 364 mg  in 1000 mg
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) 71 mg  in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N) 89 mg  in 1000 mg
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) 36 mg  in 1000 mg
NUTMEG OIL (UNII: Z1CLM48948) 133 mg  in 1000 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69804-001-0156700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/20/2015
2NDC: 69804-001-04113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/07/2015
3NDC: 69804-001-0728500 mg in 1 BOTTLE, SPRAY; 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(69804-001)

Revised: 11/2017
 
Ridge Properties


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