Label: EQUATE COLD THERAPY PAIN RELIEVING ROLL-ON ANALGESIC- menthol, unspecified form gel
- NDC Code(s): 79903-022-01
- Packager: Wal-Mart Stores, Inc.
- Category: HUMAN OTC DRUG LABEL
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 February 10, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
- ♦
- Avoid contact with eyes
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- Do not apply to wounds or damaged skin
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- Do not use with other ointments, creams sprays or liniments
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- Do not apply to irritated skin or if excessive irritation develops
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- Do not bandage tightly
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- Wash hands after use with cool water
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- Do not use with heating pads or heating devices
- Directions
- Other information
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Inactive ingredients
aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label
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INGREDIENTS AND APPEARANCE
EQUATE COLD THERAPY PAIN RELIEVING ROLL-ON ANALGESIC
menthol, unspecified form gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Arnica Montana Flower (UNII: OZ0E5Y15PZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) Calendula Officinalis Flower (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Glycerin (UNII: PDC6A3C0OX) Isopropyl Alcohol (UNII: ND2M416302) Isopropyl Myristate (UNII: 0RE8K4LNJS) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Sodium Hydroxide (UNII: 55X04QC32I) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Water (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-022-01 74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 01/14/2021 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC. 255106239 MANUFACTURE(79903-022)