Arnica Gel by Sled Distribution, LLC Arnica Gel

Arnica Gel by

Drug Labeling and Warnings

Arnica Gel by is a Homeopathic medication manufactured, distributed, or labeled by Sled Distribution, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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Arnica Gel

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana -7%

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

UsesTemporarily relieves muscle pain and stiffness due to:

• minor injuries
• overexertion
• falls 
• reduces symptoms of bruising such as : discoloration, pain, swelling.

Warnings:

• For external use only. Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.
• If pregnant or breast-feeding,ask a health professional before use.
• Nursing mothers should not apply to breast area.
• Keep out of reach of children.

• Stop use and ask a doctor if: symptoms worsen or do not improve within 3 days skin irritation, redness or rash occurs.

• If swallowed, get medical help or contact a Poison Control Center immediately.

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:

• Do not use if carton or tube seal is broken.

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

Drug Facts

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Active ingredients                                   Purpose

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

ARNICA GEL 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81417-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81417-123-01	1 in 1 PACKET	03/24/2022
1		3.5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/24/2022	11/24/2024

Labeler - Sled Distribution, LLC (079772888)

Registrant - Sled Distribution, LLC (079772888)

Establishment
Name	Address	ID/FEI	Business Operations
Sled Distribution, LLC		079772888	manufacture(81417-123)

Revised: 11/2025

Document Id: 445c3379-d0e0-7420-e063-6294a90a574a

34390-5

Set id: adb355fa-8bc4-48f5-90ab-098d95dcfd1a

Version: 2

Effective Time: 20251124