Dr. Richs Numbing (Lidocaine) Gel [Genz Online Llc] -

DR. RICHS NUMBING (LIDOCAINE) GEL [GENZ ONLINE LLC]
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NDC	69191-500-06
Set ID	a346a2d3-a48d-4915-b09f-ebc04b7a1670
Category	HUMAN OTC DRUG LABEL
Packager	GenZ Online LLC
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Dr. Rich's Numbing Gel
ACTIVE INGREDIENT

Active Ingredient / Purpose

Lidocaine 4% / Topical Anesthetic
Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Carbomer, Ethylhexylglycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Triethanolamine.
Uses:
Temporarily relieves pain associated with
- minor cuts
- minor skin abrasions
- scrapes
- minor burns
Warnings:
- For external use only
- Avoid contact with eyes
- Do not use in large quantities particularly over raw surfaces or blistered areas.
Stop use and see a doctor if:
- allergic reaction occurs
- symptoms persist for more than seven days.
Keep out of the reach of children.

Do not use if nursing or pregnant.
Directions:
- Apply externally directly to affected area
- Children under two-years of age: consult a doctor.
Dr. Rich's Numbing Gel 0.6g (69191-500-06)

INGREDIENTS AND APPEARANCE

DR. RICHS NUMBING
lidocaine gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69191-500-06	0.6 g in 1 PACKET; Type 0: Not a Combination Product	02/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/27/2014

Labeler - GenZ Online LLC (054271870)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(69191-500)

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