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Real Time Pain Relief Cream

Medically reviewed on December 29, 2017

Dosage form: lotion
Ingredients: MENTHOL 1.25g in 100mL
Labeler: Cosmetic Specialty Labs, Inc.
NDC Code: 58133-600

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

Active Ingredient

Menthol 1.25%

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:

‚Äčadults 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 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

REAL TIME PAIN RELIEF CREAM 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-600
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
CAPSICUM FRUTESCENS WHOLE 
ANTHEMIS ARVENSIS FLOWERING TOP 
BUTYLENE GLYCOL 
CARBOMER 940 
CORIANDRUM SATIVUM WHOLE 
WATER 
CALENDULA OFFICINALIS SEED OIL 
CENTAUREA CYANUS FLOWER 
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) 
HYPERICUM PERFORATUM 
PHENOXYETHANOL 
EMU OIL 
CETOSTEARYL ALCOHOL 
DIAZOLIDINYL UREA 
GLUCOSAMINE HYDROCHLORIDE 
HAMAMELIS VIRGINIANA BARK 
SALIX ALBA BARK 
TERT-BUTYL ALCOHOL 
MATRICARIA CHAMOMILLA FLOWERING TOP OIL 
3,4-METHYLENEDIOXYBENZYL METHYLSULFONE 
CETYL ALCOHOL 
CAPRYLYL GLYCOL 
SORBITOL 
TILIA CORDATA FLOWER 
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) 
Packaging
#Item CodePackage Description
1NDC:58133-600-1545 mL in 1 TUBE
2NDC:58133-600-07210 mL in 1 TUBE
3NDC:58133-600-04120 mL in 1 BOTTLE, PUMP
4NDC:58133-600-12354 mL in 1 BOTTLE, PUMP
5NDC:58133-600-16473 mL in 1 BOTTLE, PUMP
6NDC:58133-600-40120 mL in 1 TUBE
7NDC:58133-600-3398 mL in 1 TUBE
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/FEIOperations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-600)

 
Cosmetic Specialty Labs, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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