HOMEOPATHIC LIP BALM- arnica montana ointment

Homeopathic Lip Balm by

Drug Labeling and Warnings

Homeopathic Lip Balm by is a Homeopathic medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Arnica Montana (2X H.P.U.S.)

*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Pain

Uses

Temporarily relieves symptoms of pain and inflammation.

Warnings

For external use only.

• If swallowed, get medical help or contact a Poison Control Center Immediately.
• Test for allergy by rubbing small amount on skin first.
• Do not use if allergic to or hypersensitive to any ingredient.
• If condition worsens or does not improve consult a doctor.

When using this product

• Avoid contact with eyes

Stop use and ask a doctor if:

• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• Redness is present
• Irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep all medicines out of reach of children.

Directions

Apply to affected area 2 times daily or as needed.

Inactive Ingredients

Petrolatum, Synthetic Beeswax, Isopropyl Palmitate, Menthol, Lanolin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Natural Flavor, Lavandula Angustifolia (Lavender) Oil, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Butyrospermum Parkii (Shea) Butter, Mentha Piperita (Peppermint) Leaf Oil, Isopropyl Myristate, Also Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) See Oil, Camphor, Butylene Glycol, Stevia Rebaudiana Leaf/Stem Extract.

Principal Display Panel, Drug Facts

INGREDIENTS AND APPEARANCE

HOMEOPATHIC LIP BALM 
arnica montana ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-111
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

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR LEAF OIL (UNII: 51D0RGY52V)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
PETROLATUM (UNII: 4T6H12BN9U)
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)
BUTYROSPERMOL (UNII: 6SF0L0FL42)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
LANOLIN (UNII: 7EV65EAW6H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-111-05	15 g in 1 JAR; Type 0: Not a Combination Product	01/01/2015
2	NDC: 58133-111-01	5.5 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2015

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-111)