Real Time Pain Relief MAXX Topical Analgesic Lotion

Real Time Pain Relief MAXX Topical Analgesic Lotion

Drug Labeling and Warnings

Drug Details

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REAL TIME PAIN RELIEF MAXX TOPICAL ANALGESIC- menthol 1.5% 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 MAXX Topical Analgesic Lotion

Drug Facts

Active Ingredient

Menthol 1.5%

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
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

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 2 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 2 years or younger: ask a doctor

Inactive ingredients

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

Distributed by: RTPR LLC, Edmond, OK 73012

Principal Display Panel and Drug Facts

labeling

REAL TIME PAIN RELIEF MAXX  TOPICAL ANALGESIC
menthol 1.5% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58133-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
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)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
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)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58133-100-3397.5 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2015
2NDC: 58133-100-04120 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2014
3NDC: 58133-100-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2014
4NDC: 58133-100-12473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2014
5NDC: 58133-100-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2014
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-100)

Revised: 1/2018
 
Cosmetic Specialty Labs, Inc.


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