Label: BLUE-EMU MAXIMUM PAIN RELIEF- trolamine salicylate cream
- NDC Code(s): 69993-300-03
- Packager: NFI, 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 April 25, 2023
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Allergy alert:
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product
- •
- use only as directed
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- do not bandage tightly or use with a heating pad
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- avoid contact with eyes or mucous membranes
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- do not apply to wounds or damaged skin.
- Directions
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Inactive ingredients
acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice (aloe vera), cetyl alcohol, dimethicone, disodium EDTA, emu oil, ethylhexylglycerin, FD & C Blue#1, glucosamine HCl, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, panthenol, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopheryl acetate (Vitamin E), water.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 88 g Tube Label
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INGREDIENTS AND APPEARANCE
BLUE-EMU MAXIMUM PAIN RELIEF
trolamine salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69993-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) EMU OIL (UNII: 344821WD61) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69993-300-03 88 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2020 Labeler - NFI, LLC (121681919) Establishment Name Address ID/FEI Business Operations Gregory Pharmaceutical Holdings, Inc. dba UPM Pharmaceuticals 081301372 MANUFACTURE(69993-300)