Label: FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING- menthol gel
- NDC Code(s): 62217-080-33, 62217-080-34
- Packager: Fruit of the Earth, 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 July 30, 2021
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- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOCETETH-20 (UNII: O020065R7Z) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) SULISOBENZONE (UNII: 1W6L629B4K) EDETATE SODIUM (UNII: MP1J8420LU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-080-33 113 g in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2013 2 NDC:62217-080-34 340 g in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/30/2013 Labeler - Fruit of the Earth, Inc. (079559467)