Label: REVIVE 2- menthol liquid
- NDC Code(s): 69678-424-04
- Packager: EEZAWAY RELIEF INC
- 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 May 17, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient:
- Purpose
- Uses
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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 eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation or redness may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight
Stop use and ask a doctor if • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable • keep away from fire or flame
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
REVIVE 2
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69678-424 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2.75 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) SUNFLOWER OIL (UNII: 3W1JG795YI) PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) ISOPROPYL ALCOHOL (UNII: ND2M416302) OLETH-10 (UNII: JD797EF70J) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) SODIUM THIOSULFATE (UNII: HX1032V43M) IODINE (UNII: 9679TC07X4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69678-424-04 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/17/2022 Labeler - EEZAWAY RELIEF INC (109456638)