Label: MIRACLE OF ALOE RUB ROLL ON- menthol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66391-0046-0 - Packager: Winning Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 4, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIRACLE OF ALOE RUB ROLL ON
menthol liquidProduct 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