Miracle Pain Cream

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

Medically reviewed by Drugs.com. Last updated on Sep 23, 2024.

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
1	NDC:58133-049-04	115 g in 1 TUBE

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

Document Id: 20453893-3b4e-4eb5-9d1b-e2afef350940

Set id: 51b386b3-85ac-4ae6-b879-20a6b9bc4578

Version: 1

Effective Time: 20131002

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