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 ingredients:

Arnica montana 7%

Purpose

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

WarningsFor external use only.

DO NOT USE

Do not use if you are allergic to Arnica montana or any of this product's inactive ingredients.

WHEN USING

When using this product

• avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
• dryness or irritation may occur
• use only as directed
• do not tightly wrap or bandage the treated area
• do not apply heat or ice to the treated area immediately before or after use.

STOP USE

Stop use and ask a doctor if

• Conditions persist for more than 3 days or worsens
• Symptoms clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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 gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.

OTHER SAFETY INFORMATION

Other information do not use if the sachet seal is broken.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA GEL 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81417-005
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: 81417-005-01	3.5 g in 1 POUCH; Type 0: Not a Combination Product	08/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/29/2022

Labeler - Sled Distribution, LLC (079772888)