MIRACLE RUB- menthol, methyl salicylate cream

Miracle Rub by

Drug Labeling and Warnings

Miracle Rub by is a Other medication manufactured, distributed, or labeled by Winning Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Menthol 2.5%

                          Methylsalieylate 10.0%

PURPOSE

Purpose : External Analgesic

WARNINGS

Warnings: For external use only .

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

Directions :  adults and  children 12 years and older apply to affected area no more than 3 to 4 times daily

                  under 12 years ask a doctor before use

INDICATIONS & USAGE

Uses: Temporarly relieves minor aches and pains of muscles and joints due to

• arthritis
• simple backache
• strains
• sprains
• bruises

INACTIVE INGREDIENT

aloe barabardensis leaf Juice, water, stearic acid, cetyl alcohol, glyceryl stearate, PEG-100 stearte, petrolatum, dimethicone, triethanolamine, eucalyptus globulus leaf oil, imidazolidinyl urea, methylparaben, propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLE RUB 
menthol, methyl salicylate cream

Product Information
Product Type	COSMETIC	Item Code (Source)	66391-1603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 106 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10.0 g  in 106 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)
Stearic Acid (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MANGO (UNII: I629I3NR86)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	66391-1603-4	112 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/31/2016

Labeler - Winning Solutions (962718300)

Registrant - Winning Solutions (962718300)