Label: MEIJER COLD THERAPY PAIN RELIEVING ANALGESIC- menthol, unspecified form gel
- NDC Code(s): 79481-0087-1
- Packager: MEIJER DISTRIBUTION, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 28, 2024
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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 the eyes
- ⬥
- 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 irritation develops
- ⬥
- Do not bandage tightly
- ⬥
- Wash hands after use with cool water
- ⬥
- Do not use with heating pads or heating devices.
- Directions
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 89 mL Tube Label
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INGREDIENTS AND APPEARANCE
MEIJER COLD THERAPY PAIN RELIEVING ANALGESIC
menthol, unspecified form gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0087 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:79481-0087-1 89 mL in 1 TUBE; Type 0: Not a Combination Product 11/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 11/03/2023 Labeler - MEIJER DISTRIBUTION, INC (006959555) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC 255106239 MANUFACTURE(79481-0087) , LABEL(79481-0087) , PACK(79481-0087)