EXTRA STRENGTH WOUND CARE- lidocaine hcl cream
Ridge Proeprties

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 WOUND CARE
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-054
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
PROPOLIS WAX (UNII: 6Y8XYV2NOF)	40 mg in 1000 mg
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W)	190 mg in 1000 mg
WITCH HAZEL (UNII: 101I4J0U34)	400 mg in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N)	90 mg in 1000 mg
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)	120 mg in 1000 mg
NUTMEG OIL (UNII: Z1CLM48948)	60 mg in 1000 mg
ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43)	60 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69804-054-06	14200 mg in 1 JAR; Type 0: Not a Combination Product	05/01/2017
2	NDC:69804-054-05	28500 mg in 1 JAR; Type 0: Not a Combination Product	05/01/2017
3	NDC:69804-054-02	56700 mg in 1 JAR; Type 0: Not a Combination Product	05/01/2017
4	NDC:69804-054-03	113400 mg in 1 JAR; Type 0: Not a Combination Product	05/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2017

Labeler - Ridge Proeprties (029478762)

Name	Address	ID/FEI	Business Operations
Establishment
ridge properties		029478762	manufacture(69804-054)