ARNICA GEL- arnica montana gel 
Sled Distribution, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Arnica Gel

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana -7%

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

Uses Temporarily relieves muscle pain and stiffness due to:

Warnings:

Directions: Apply a thin layer of get to affected area as soon as possible after minor injure. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying ointment.

Other information:

Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose

Arnica montana.......................................Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

image description

ARNICA GEL 
arnica montana gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81417-123-011 in 1 PACKET03/24/2022
13.5 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/24/2022
Labeler - Sled Distribution, LLC (079772888)
Registrant - Sled Distribution, LLC (079772888)
Establishment
NameAddressID/FEIBusiness Operations
Sled Distribution, LLC079772888manufacture(81417-123)

Revised: 3/2022
Document Id: 3ae316c7-5a85-4098-b6a2-38ebe8ec551d
Set id: adb355fa-8bc4-48f5-90ab-098d95dcfd1a
Version: 1
Effective Time: 20220324
 
Sled Distribution, LLC