REAL TIME PAIN RELIEF SPORTS CREAM TOPICAL ANALGESIC- menthol 0.5% lotion 
Cosmetic Specialty labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Real Time Pain Relief Sports Cream

ACTIVE INGREDIENT

Menthol 0.5%

PURPOSE

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

USES

Temporarily relieves minor pain associated with

WARNINGS

for external use only

When using this product

  • use only as directed
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop using 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

If pregnant or breast-feeding

ask a health professional before use

DIRECTIONS

adults and children over 2 years

  • apply generously to affected area
  • massage into painful area until throughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

children 12 years or younger

ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

PRINCIPAL DISPLAY PANEL

Label

REAL TIME PAIN RELIEF SPORTS CREAM  TOPICAL ANALGESIC
menthol 0.5% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARBOMER 934 (UNII: Z135WT9208)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CORIANDER OIL (UNII: 7626GC95E5)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
EMU OIL (UNII: 344821WD61)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
WATER (UNII: 059QF0KO0R)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
SORBITOL (UNII: 506T60A25R)  
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
MYRISTICA FRAGRANS WHOLE (UNII: MF7T8BM40A)  
TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATE (UNII: E6DVO371LC)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
2-(DIPROPYLAMINO)ETHANOL (UNII: 0916206V9S)  
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ORIGANUM MAJORANA (UNII: R40XM3HU5X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-700-04120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
2NDC:58133-700-12345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
3NDC:58133-700-40120 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
4NDC:58133-700-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2013
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Registrant - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-700)

Revised: 1/2018
Document Id: 61d18e02-8b45-7c40-e053-2991aa0afbd2
Set id: 61d18e02-8b44-7c40-e053-2991aa0afbd2
Version: 1
Effective Time: 20180102
 
Cosmetic Specialty labs, Inc.