BUMPS N BRUISES- arnica montana root ointment

BUMPS N BRUISES by

Drug Labeling and Warnings

BUMPS N BRUISES by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS

A homeopathic medicine for the temporary relief of symptoms of bruising and swelling from falls, trauma or overexertion.

FORMULA

An extract of Arnica Montana 1X HPUS in a base of petrolatum, USP, Beeswax, NF, Methylparaben, NF and Propylparaben, NF.

DIRECTIONS

Children 2 years to under 12 years

Wash affected area with lukewarm water and apply freely as needed; or as recommended by a licensed health care provider.

Do not use on broken skin.

Warnings

Do not use if tamper band is broken or missing.

For external use only.

If symptoms persist for more than 7 days or worsen, consult a licensed health care professional.

Keep this and all medications out of the reach of children.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

In case of accidental overdose, contact a poison control center immediately.

In case of emergency, the manufacturer may be reached 24 hours a day.

QUESTIONS?

CALL US: 800/624-9659

PRINCIPAL DISPLAY PANEL - 8gm Tube Label

NDC: 54973-7510-1

Hyland's®
HOMEOPATHIC

Hyland's
Bumps 'n
Bruises™
Ointment

With
Arnica

.26 oz (8gm)

INGREDIENTS AND APPEARANCE

BUMPS N BRUISES 
arnica montana root ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-7510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	1 [hp_X]  in 8 g

Inactive Ingredients
Ingredient Name	Strength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-7510-1	1 in 1 BLISTER PACK	10/18/2001
1		8 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/18/2001

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-7510) , pack(54973-7510)