Arnica by Humco Holding Group, Inc. ARNICA liquid

Arnica by

Drug Labeling and Warnings

Arnica by is a Homeopathic medication manufactured, distributed, or labeled by Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HUMCO Arnica Tincture

Drug Facts

Active Ingredient

Arnica Flowers, 20 grams per 100cc of tincture

Purpose

Soreness relief

USE:

For the temporary relief of bruises and soreness.

Warnings

When using this product

do not apply to irritated skin. Avoid getting into eyes or on mucous membranes.

Stop use and consult a doctor

if a rash or excessive irritation of the skin develops.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. If pregnant or breastfeeding ask a health professional before use.

Directions

• When applied as a tincture, dilute with one or two parts of Rubbing Alcohol.
  
• May be added to hot water that is being used in hot packs.
  
• Apply to affected area, repeat as needed.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, cure, treat or prevent any disease.

Inactive Ingredient

Isopropyl Alcohol and Purified Water.

Other Information

• Flammable: Keep away from spark, heat and flame. Store in cool dry place.

Principal Display Panel

NDC: 0395-0115-94
ARNICA TINCTURE
Soreness relief
4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

ARNICA 
arnica liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-0115-94	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1997	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/1997	06/30/2022

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-0115) , analysis(0395-0115) , pack(0395-0115) , label(0395-0115)