HOMEOPATHIC LIP BALM- arnica montana ointment 
Cosmetic Specialty Labs, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Real Time Pain Relief Homeopathic Lip Balm

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.

When using this product

Stop use and ask a doctor if:

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

labeling

HOMEOPATHIC LIP BALM 
arnica montana ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-111-0515 g in 1 JAR; Type 0: Not a Combination Product01/01/2015
2NDC:58133-111-015.5 g in 1 TUBE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2015
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-111)

Revised: 1/2018
Document Id: 62478131-4ed8-5407-e053-2991aa0a5aac
Set id: 62478131-4ed7-5407-e053-2991aa0a5aac
Version: 1
Effective Time: 20180108
 
Cosmetic Specialty Labs, Inc.