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

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.