WHITE REAL TIME PAIN RELIEF TOPICAL ANALGESIC- menthol 1% 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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White Real Time Pain Relief

Topical Analgesic

Drug Facts

Active Ingredient

Menthol 1.0%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

for external use only

When using this product

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

Stop use 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

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

children 12 years or younger: ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Calendula officinalis 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 HCl, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Methylsulfonylmethane, Phenoxyethanol, Pimpinella Anisum (Anise) Fruit Extract, Purified Water, Ruta Graveolens (Rue) Leaf/Root/Stem Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia sylvestris Extract, Triethanolamine.

Distributed by: RTPR LLC, Edmond, OK 73012

PRINCIPAL DISPLAY PANEL - 44 mL Tube Label

PARABEN &
SLS FREE

$10

RTPR!com
REAL
TIME
Pain Relief ®

Relief in Minutes!

TESTED & PROVEN

WORKS FOR:
Arthritis, Simple Backaches,
Muscle Strains, Sprains,
Bruises & Cramps.

Topical Analgesic
Lotion

New Wt. 1.5 Fl. Oz. / 44 mL

Principal Display Panel - 44 mL Tube Label
WHITE REAL TIME PAIN RELIEF  TOPICAL ANALGESIC
menthol 1% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 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)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPSICUM (UNII: 00UK7646FG)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CORIANDER OIL (UNII: 7626GC95E5)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EMU OIL (UNII: 344821WD61)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ANISE (UNII: 21C2F5E8RE)  
WATER (UNII: 059QF0KO0R)  
RUTA GRAVEOLENS FLOWERING TOP OIL (UNII: VDI0O08XRA)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
SORBITOL (UNII: 506T60A25R)  
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-051-1544 mL in 1 TUBE; Type 0: Not a Combination Product03/15/201301/01/2018
2NDC:58133-051-40118 mL in 1 TUBE; Type 0: Not a Combination Product03/15/201301/01/2018
3NDC:58133-051-70207 mL in 1 TUBE; Type 0: Not a Combination Product03/15/201301/01/2018
4NDC:58133-051-17473 mL in 1 CYLINDER; Type 0: Not a Combination Product03/15/201301/01/2018
5NDC:58133-051-3089 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/201301/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/201301/01/2018
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-051)

Revised: 1/2018
Document Id: 638803d2-a15a-486d-e053-2991aa0ab074
Set id: 0222a9e1-68f6-4b81-9df2-ed9eeecb7f95
Version: 3
Effective Time: 20180124
 
Cosmetic Specialty labs, Inc.