Skip to main content

The originating document has been archived. We cannot confirm the completeness, accuracy, or currency of the content.

Real Time Pain Relief Topical Analgesic

Dosage form: lotion
Ingredients: menthol 1g in 100mL
Labeler: Cosmetic Specialty labs, Inc.
NDC code: 58133-052

ACTIVE INGREDIENT

Menthol 1%

PURPOSE

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

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 mucus membranes
  • do not apply to wounds or damaged skin

Stop using 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 deveops

If pregnant or breast-feeding

ask a health professional before use

DIRECTIONS

adults and children over 12 years
  • apply generously to affected area
  • massage into painful area until throughly 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, Blue 1, Calendula officinalis Extract, 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, Methylparaben, Methysulfonylmethane, Pimpinella Anisum (Anise) Fruit Extract, Propylparaben, 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.

PRINCIPAL DISPLAY PANEL

REAL TIME PAIN RELIEF  TOPICAL ANALGESIC
menthol 1% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (MENTHOL) menthol1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CHAMAEMELUM NOBILE FLOWER 
ARNICA MONTANA FLOWER 
FD&C BLUE NO. 1 
CALENDULA OFFICINALIS FLOWER 
CAPSICUM 
CARBOMER 934 
CENTAUREA CYANUS FLOWER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CORIANDER OIL 
DIAZOLIDINYL UREA 
EMU OIL 
GLUCOSAMINE HYDROCHLORIDE 
HAMAMELIS VIRGINIANA TOP 
METHYLPARABEN 
DIMETHYL SULFONE 
ANISE 
PROPYLPARABEN 
WATER 
RUTA GRAVEOLENS FLOWERING TOP OIL 
SALIX ALBA BARK 
ISOPROPYL ALCOHOL 
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) 
SORBITOL 
TILIA X EUROPAEA FLOWER 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:58133-052-0259 mL in 1 TUBE
2NDC:58133-052-0389 mL in 1 BOTTLE
3NDC:58133-052-05148 mL in 1 TUBE
4NDC:58133-052-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2013
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIOperations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-052)

Revised: 03/2013
Document Id: 3d4dd63b-b02e-464d-aa9e-6a0b3471aa26
Set id: 49922962-cf03-421b-ae91-9581a7daf81e
Version: 1
Effective Time: 20130327
 
Cosmetic Specialty labs, Inc.

Further information

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

Medical Disclaimer