RHEMU- rhemu analgesic cream
Galxee, Inc.

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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RHEMU

Active Ingredients

Methyl Salicylate 10%

Menthol 7%

Warnings

For external use only

When using this product

use only as directed

do not get into eyes or mucous membranes

do not apply to wounds or damaged skin

do not bandage tightly

Stop use and ask a doctor if

condition worsens

excessive irritation, burning or discomfort of the skin develops

symptioms persist for more than 7 days

do not use if pregnant or breast feeding

Keep away from children to avoid accidential poisoning. If swallowed, get medical help or contact a Poison Control Center immediately.

Topical Analgesic

Directions

Adults and children 12 years and over

Apply to affected area not more than 3 to 4 times daily

Children under 12 years: ask a doctor

Other Information

Store at room temperature (59-86ºF)

Inactive Ingredients

Purified Water, C12-15 Alkyl Benzoate, Emu Oil, Glycerin, Eucalyptus Globulus Oil, Stearic Acid, Potassium Cetyl Phosphate, Glyceryl Stearate, Carbomer, Persea Grastissima (Avocado) Oil, Sodium Hydroxide, Disodium EDTA, Phenethyl Alcohol, Caprylyl Glycol, Ethylhexylglycerin, Arnica Montana Flower Extract.

Image of Carton Label

RHEMU
rhemu analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69743-513
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.07 g in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EMU OIL (UNII: 344821WD61)
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CARBOMER 1342 (UNII: 809Y72KV36)
AVOCADO OIL (UNII: 6VNO72PFC1)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69743-513-23	1 in 1 BOX	12/15/2014	05/31/2017
1		170 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/15/2014	05/31/2017

Labeler - Galxee, Inc. (079610468)

Name	Address	ID/FEI	Business Operations
Establishment
CHEMOLEE Lab Corporation		809982754	manufacture(69743-513)

Revised: 3/2018

Document Id: 67db3d1b-7491-5d3c-e053-2991aa0a3dd8

Set id: 07962bd1-ef62-1505-e054-00144ff8d46c

Version: 2

Effective Time: 20180320

Galxee, Inc.