EXTRA STRENGTH FIRST AID- 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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EXTRA STRENGTH FIRST AID
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69804-052
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
ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43)	75 mg in 1000 mg
WITCH HAZEL (UNII: 101I4J0U34)	510 mg in 1000 mg
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W)	200 mg in 1000 mg
COPAIBA OIL (UNII: 64VX45Y68N)	100 mg in 1000 mg
NUTMEG OIL (UNII: Z1CLM48948)	75 mg in 1000 mg

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69804-052-08	14200 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2017
2	NDC:69804-052-07	28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2017
3	NDC:69804-052-01	56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2017
4	NDC:69804-052-04	113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/14/2017

Labeler - ridge properties (029478762)

Name	Address	ID/FEI	Business Operations
Establishment
ridge properties		029478762	manufacture(69804-052)