Label: RITE AID ROLL-ON- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76168-313-47 - Packager: Velocity Pharma LLC
- 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 October 1, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses:
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Warnings:
For external use only
When using this product:
- Avoid contact with eyes or mucous membranes
- Do not apply to wounds or damaged skin.
- Do not use with other ointments, creams, sprays, or liniments.
- Do not apply to irritated skin or if excessive skin irritation develops.
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device.
- Directions
- Inactive Ingredients:
- Other Information:
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RITE AID ROLL-ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-313-47 1 in 1 CARTON 07/17/2018 1 73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/17/2018 Labeler - Velocity Pharma LLC (962198409)