Miracle Pain Cream: Package Insert and Label Information

MIRACLE PAIN CREAM- menthol cream
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.

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

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MIRACLE PAIN CREAM
menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-049
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
menthol (MENTHOL) menthol 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:58133-049-04 115 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/01/2012
Labeler — Cosmetic Specialty labs, Inc. (032973000)
Establishment
Name Address ID/FEI Operations
Cosmetic Specialty labs, Inc. 032973000 manufacture (58133-049)

Revised: 10/2013 Cosmetic Specialty labs, Inc.

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