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Miracle Pain Cream

Medically reviewed on October 2, 2017

Dosage form: cream
Ingredients: menthol 3g in 100g
Labeler: Cosmetic Specialty labs, Inc.
NDC Code: 58133-049

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.

ACTIVE INGREDIENT

Menthol 3.0%

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 the eyes or mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if
  • condition worsens
  • symptoms perist for more than 7days 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

DIRECTIONS

Adults and children over 12 years
  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into the skin
  • repeat as necessary, no more than 4 times daily

Children 12 years or younger

ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Cymbopogon Martinii (Palmarosa) Oil, Eucalyptus Globulus Leaf Oil, Hamamelis Virginiana (Witch Hazel) Bark / Leaf / Twig Extract, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, Sorbitol, Tocopheryl Acetate, Triethanolamine.

PRINCIPAL DISPLAY PANEL

MIRACLE PAIN CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-049
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (MENTHOL) menthol3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
BUTYLENE GLYCOL  
CAPRYLYL GLYCOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
ORANGE OIL 
PALMAROSA OIL 
EUCALYPTUS OIL 
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 
LAVENDER OIL 
MENTHA PIPERITA LEAF 
DIMETHYL SULFONE 
PHENOXYETHANOL 
WATER 
SALIX ALBA BARK 
SORBITOL 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:58133-049-04115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2012
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIOperations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-049)

 
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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