REAL TIME PAIN RELIEF CREAM- menthol 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 Cream

Active Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

for external use only

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

​adults and children over 2 years:

children 2 years or younger: ask a doctor

Inactive ingredients:

Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.

Package Label, Principal Display Panel and Drug Facts

labeling

REAL TIME PAIN RELIEF CREAM 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CAPSICUM FRUTESCENS WHOLE (UNII: 6XJX33L87P)  
ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)  
WATER (UNII: 059QF0KO0R)  
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EMU OIL (UNII: 344821WD61)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
3,4-METHYLENEDIOXYBENZYL METHYLSULFONE (UNII: 4W601CSX19)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBITOL (UNII: 506T60A25R)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-600-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
2NDC:58133-600-07210 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
3NDC:58133-600-04120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/30/2013
4NDC:58133-600-12354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/30/2013
5NDC:58133-600-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/30/2013
6NDC:58133-600-40120 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
7NDC:58133-600-3398 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
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(58133-600)

Revised: 12/2017
Document Id: 617d4c4c-c541-f7a3-e053-2991aa0afc0e
Set id: 617d4c4c-c540-f7a3-e053-2991aa0afc0e
Version: 1
Effective Time: 20171229
 
Cosmetic Specialty Labs, Inc.