YOWCH EXTRA STRENGTH FOR MINOR BURNS- 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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YOWCH EXTRA STRENGTH FOR MINOR BURNS
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-006
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
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)	60 mg in 1000 mg
MANGO SEED OIL (UNII: K8LOR30915)	35 mg in 1000 mg
PROPOLIS WAX (UNII: 6Y8XYV2NOF)	15 mg in 1000 mg
COCONUT OIL (UNII: Q9L0O73W7L)	25 mg in 1000 mg
WALNUT OIL (UNII: Y0P3555R51)	25 mg in 1000 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	70 mg in 1000 mg
EUCALYPTUS OIL (UNII: 2R04ONI662)	25 mg in 1000 mg
NUTMEG OIL (UNII: Z1CLM48948)	5 mg in 1000 mg
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)	25 mg in 1000 mg
ALMOND OIL (UNII: 66YXD4DKO9)	25 mg in 1000 mg
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)	25 mg in 1000 mg
COCOA BUTTER (UNII: 512OYT1CRR)	25 mg in 1000 mg
WITCH HAZEL (UNII: 101I4J0U34)	600 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69804-006-02	56700 mg in 1 JAR; Type 0: Not a Combination Product	11/30/2015
2	NDC:69804-006-03	113400 mg in 1 JAR; Type 0: Not a Combination Product	11/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/30/2015

Labeler - Ridge Properties (029478762)

Name	Address	ID/FEI	Business Operations
Establishment
Ridge Properties		029478762	manufacture(69804-006)