Label: EMUAID PAIN RELIEVING- menthol, unspecified form cream
- NDC Code(s): 55926-0026-1
- Packager: Speer Laboratories 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 June 23, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only. When using this product
- Do not bandage tightly
- Avoid contact with the eyes
- Do not apply to wounds or damaged skin
- Do not use a heating pad or other heating devices
- Directions
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Inactive Ingredients
Water (Aqua), Emu Oil/Hemp Extract, Glycerin, Potassium Cetyl Phosphate, Rhus Verniciflua Peel Cera (Berry Wax), Glyceryl Stearate, Ethyl Macadamiate, Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Polysorbate 60, Sorbitan Olivate, Mentha Piperita Oil, Tocopherol, Lavendula Officinalis (Lavender) Oil, Sodium Benzoate, Sodium Levulinate, Juniperus Communis (Juniper) Oil, Allantoin, Calophyllum Inophyllum Seed Oil, Borago Officinalis Extract, Boswellia Serrata Resin Extract, Carrageenan, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Eugenia Caryophyllata (Clove) Oil, Gaultheria Procumbens (Wintergreen) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Chamomilla Recutita Flower Extract.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 G Tube Label
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INGREDIENTS AND APPEARANCE
EMUAID PAIN RELIEVING
menthol, unspecified form creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55926-0026 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 2.4 g in 120 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Emu Oil (UNII: 344821WD61) CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D) Glycerin (UNII: PDC6A3C0OX) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH) Glyceryl Monostearate (UNII: 230OU9XXE4) Ethyl Macadamiate (UNII: ANA2NCS6V1) Arnica Montana Flower (UNII: OZ0E5Y15PZ) SHEA BUTTER (UNII: K49155WL9Y) Cetearyl Olivate (UNII: 58B69Q84JO) Polysorbate 60 (UNII: CAL22UVI4M) Sorbitan Olivate (UNII: MDL271E3GR) Peppermint Oil (UNII: AV092KU4JH) Tocopherol (UNII: R0ZB2556P8) LAVENDER OIL (UNII: ZBP1YXW0H8) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Levulinate (UNII: VK44E1MQU8) JUNIPER BERRY OIL (UNII: SZH16H44UY) Allantoin (UNII: 344S277G0Z) Tamanu Oil (UNII: JT3LVK84A1) BORAGE (UNII: PB618V0K2W) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) Carrageenan (UNII: 5C69YCD2YJ) Jojoba Oil (UNII: 724GKU717M) Sodium Hydroxide (UNII: 55X04QC32I) CLOVE OIL (UNII: 578389D6D0) Gaultheria Procumbens Leaf (UNII: 2125M16OWN) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55926-0026-1 120 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/09/2023 Labeler - Speer Laboratories LLC (064900125) Establishment Name Address ID/FEI Business Operations Ariel Laboratories LP 087625133 MANUFACTURE(55926-0026)