Medterra Pain Cream 500 by RNA PHARMA, LLC

Medterra Pain Cream 500 by

Drug Labeling and Warnings

Medterra Pain Cream 500 by is a Otc medication manufactured, distributed, or labeled by RNA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDTERRA PAIN CREAM 500- menthol cream 
RNA PHARMA, LLC

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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MEDTERRA PAIN CREAM 500 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60717-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	0.07 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ROSEMARY (UNII: IJ67X351P9)
TOCOPHEROL (UNII: R0ZB2556P8)
ARGAN OIL (UNII: 4V59G5UW9X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SHEA BUTTER (UNII: K49155WL9Y)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
RICE BRAN (UNII: R60QEP13IC)
BENTONITE (UNII: A3N5ZCN45C)
CANNABIDIOL (UNII: 19GBJ60SN5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITAN OLIVATE (UNII: MDL271E3GR)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60717-218-50	1 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/11/2021	05/20/2021

Labeler - RNA PHARMA, LLC (079103999)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(60717-218)

Revised: 12/2021

Document Id: d427b482-a2ce-e960-e053-2a95a90a325b

34390-5

Set id: bb14cafb-a8f5-5b6a-e053-2995a90ab47a

Version: 2

Effective Time: 20211227