REAL TIME PAIN RELIEF VEGAN SELECT- 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.

----------

Real Time Pain Relief Cream Vegan Select

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, Arnica Montana Flower Extract, Butylene Glycol , Calendula officinalis, Caprylyl Glycol, Capsicum Frutescens Fruit Extract, Carbomer, Centaurea cyanus, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Fragrance, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum, Matricaria chamomilla, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Rubus Idaeus (Raspberry) Seed Oil, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tilia cordata, Triethanolamine.

Package Label, Principal Display Panel and Drug Facts

labeling

REAL TIME PAIN RELIEF VEGAN SELECT 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-555
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)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
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)  
RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-555-0390 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/30/2013
2NDC:58133-555-12355 mL in 1 BOTTLE, PLASTIC; 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(58133-555)

Revised: 1/2018
Document Id: 62fb27de-beb5-8bed-e053-2991aa0a6ae1
Set id: 62fb27de-beb4-8bed-e053-2991aa0a6ae1
Version: 1
Effective Time: 20180117
 
Cosmetic Specialty Labs, Inc.