MIRACLE OF ALOE RUB ROLL ON- menthol liquid

Miracle of Aloe Rub Roll On by

Drug Labeling and Warnings

Miracle of Aloe Rub Roll On by is a Otc medication manufactured, distributed, or labeled by Winning Solutions, Beautymanufacturing Solutions Corperation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Menthol  2.0 %

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 Position Control center right away.

DOSAGE & ADMINISTRATION

Directions : adults and children 3 years and older ; apply to affected area no more than 3 to 4 times daily
             
                 under 3 years: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients : water , isopropyl alcohol , aloe barbadensis leaf juice , hydroxyethylcellulose , chamomilla recutita (matricaria) flower , eucalyptus globulus leaf oil , polysorbate 80 , fragrance , methylparaben , dmdm hydantoin

INDICATIONS & USAGE

Uses : Temporarily relieves minor aches and pains of muscles and joints due to  * arthritis  * simple backache  * strains * sprains

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

MIRACLE OF ALOE RUB ROLL ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66391-0046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	1.8 mL  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
CHAMOMILE (UNII: FGL3685T2X)
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)
polysorbate 80 (UNII: 6OZP39ZG8H)
methylparaben (UNII: A2I8C7HI9T)
dmdm hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66391-0046-0	90 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/17/2006

Labeler - Winning Solutions (962718300)

Registrant - Beautymanufacturing Solutions Corperation (783200723)

Establishment
Name	Address	ID/FEI	Business Operations
Beautymanufacturing Solutions Corperation		783200723	manufacture