REAL TIME PAIN RELIEF DAILY RELIEF- arnica montana (2x h.p.u.s.) lotion 
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 Daily Relief

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

Bruising, Stiffness, Pain

Uses:

Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

Warnings

for external use only

When using this product

avoid contact with eyes

Warnings and Precautions

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.

Stop use and ask a doctor

Keep all medicines out of reach of children.

Directions

Apply to affected area 2 times daily

Other Ingredients

Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, SD Alcohol40, Cetyl Alcohol, Carbomer, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Emu Oil, Phenoxyethanol, Caprylyl Glycol, Triethanolamine, Gycerin, Myristica Fragrans (Nutmeg) Extract, Fragrance, Diazolidinyl Urea, Salix Alba (Willow) Bark Extract, Aloe Barbadensis Leaf Juice, Menthol, Extracts of: (Calendula officianlis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recutita (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort)), Coriandrum Sativum (Coriander) Fruit Oil.

Package Label, Principal Display Panel and Drug Facts

Label

REAL TIME PAIN RELIEF DAILY RELIEF 
arnica montana (2x h.p.u.s.) lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EMU OIL (UNII: 344821WD61)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
SORBITOL (UNII: 506T60A25R)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOMER 934 (UNII: Z135WT9208)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ALOE (UNII: V5VD430YW9)  
MENTHOL (UNII: L7T10EIP3A)  
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
2,2-DICHLORO-1-(2-CHLOROPHENYL)ETHANOL (UNII: 1O5KW1KM6N)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
CLOPYRALID TRIETHANOLAMINE (UNII: O7T195VRMB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-300-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
2NDC:58133-300-04120 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
3NDC:58133-300-12345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/2014
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-300)

Revised: 1/2018
Document Id: 61e590d9-f6f5-bf71-e053-2991aa0a534d
Set id: 61e590d9-f6f4-bf71-e053-2991aa0a534d
Version: 1
Effective Time: 20180103
 
Cosmetic Specialty Labs, Inc.