EXTRA STRENGTH NUMBING GEL- 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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EXTRA STRENGTH NUMBING GEL
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-021
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
WITCH HAZEL (UNII: 101I4J0U34)	315 mg in 1000 mg
PHENOXYETHANOL (UNII: HIE492ZZ3T)	5 mg in 1000 mg
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)	110 mg in 1000 mg
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)	5 mg in 1000 mg
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)	525 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69804-021-09	14200 mg in 1 JAR; Type 0: Not a Combination Product	01/13/2017
2	NDC:69804-021-10	28500 mg in 1 JAR; Type 0: Not a Combination Product	01/13/2017
3	NDC:69804-021-11	56700 mg in 1 JAR; Type 0: Not a Combination Product	01/13/2017
4	NDC:69804-021-12	113400 mg in 1 JAR; Type 0: Not a Combination Product	01/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/13/2017

Labeler - Ridge Properties (029478762)

Name	Address	ID/FEI	Business Operations
Establishment
Ridge Properties		029478762	manufacture(69804-021)