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NDC 0536-1121-97
API & Excipient Details

Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

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Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.

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With Virupaksha, you get a quality product with on-time delivery.

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LEBSA- Your strategic API source for niche molecules.

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marketed by RUGBY LABORATORIES under NDC Code 0536-1121-97

NDC Code(s) : 0536-1121-97
Packager : RUGBY LABORATORIES

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rugby Cooling PainMENTHOL GEL

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0536-1121
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL(UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT(UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
FRANKINCENSE(UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
GLYCERIN(UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
TROLAMINE(UNII: 9O3K93S3TK)
WATER(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1121-97	118 mL in 1 TUBE Type 0: Not a Combination Product	06/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/10/2017

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