Medterra Pain Cream 1000 by RNA PHARMA, LLC / RNA PHARAMA, LLC

Medterra Pain Cream 1000 by

Drug Labeling and Warnings

Medterra Pain Cream 1000 by is a Otc medication manufactured, distributed, or labeled by RNA PHARMA, LLC, RNA PHARAMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDTERRA PAIN CREAM 1000- 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 1000 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60717-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	0.07 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60717-217-50	1 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/18/2021	11/10/2021

Labeler - RNA PHARMA, LLC (079103999)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARAMA, LLC		079103999	manufacture(60717-217)

Revised: 12/2021

Document Id: d427a68a-501d-2873-e053-2995a90ab371

34390-5

Set id: b9346293-e843-762e-e053-2a95a90a174e

Version: 2

Effective Time: 20211227