4KIDS BUMPS N BRUISES WITH ARNICA- arnica montana, bellis perennis, hypericum perforatum, and ruta graveolens flowering top ointment

4KIDS BUMPS N BRUISES with ARNICA by

Drug Labeling and Warnings

4KIDS BUMPS N BRUISES with ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, Lifetech Resources. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Arnica Montana 2X HPUS	pain, swelling, bruising, soreness, sensitivity to touch
Bellis Perennis 6X HPUS	soreness
Hypericum Perforatum 3X HPUS	pain, bruising, soreness
Ruta Graveolens 6X HPUS	aching pain, swelling, bruised sensation, soreness

Uses

Temporarily relieves the symptoms of pain, swelling, bruising, soreness and sensitivity to touch.

Warnings

For external use only. Do not take by mouth. Keep out of eyes.

Do not use on broken skin.

Stop use and ask doctor if rash occurs.

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

If swallowed, get medical help or call a Poison Control Center right away. Do not use if seal is broken.

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

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.

Other information

Protect this product from excessive heat and direct sunlight.

Inactive ingredients

Beeswax, Candelilla Wax, Carnauba Wax, Glycerine, Jojoba Oil, Lecithin, Lemongrass Oil, Olive Oil, Rosemary Oil, Tocopherol, Water, White Thyme Oil.

PRINCIPAL DISPLAY PANEL - 22.68 g Tube Blister Pack

NDC: 54973-3210-1

Bumps 'n Bruises ®

with Arnica

Safe & Effective Relief*

Bruising Pain Swelling

0.8 OZ (22.68g) OINTMENT STICK

INGREDIENTS AND APPEARANCE

4KIDS BUMPS N BRUISES WITH ARNICA 
arnica montana, bellis perennis, hypericum perforatum, and ruta graveolens flowering top ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	2 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	6 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
SPANISH THYME OIL (UNII: U14667H96E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3210-1	1 in 1 BLISTER PACK	05/28/2015
1		22.68 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		05/28/2015

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3210) , pack(54973-3210)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3210) , pack(54973-3210)