ARNICA GEL- arnica montana 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]

ACTIVE INGREDIENT

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana -7%

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

INDICATIONS & USAGE

Uses Temporarily relieves muscle pain and stiffness due to:

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

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information:

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

INACTIVE INGREDIENT

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

PURPOSE

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Labeler - Sled Distribution, LLC (079772888)

Registrant - Sled Distribution, LLC (079772888)

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