Label: MEIJER ANALGESIC WITH ALOE TOPICAL ANALGESIC- trolamine salicylate cream
- NDC Code(s): 41250-418-01
- Packager: Meijer Distribution, 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 January 20, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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
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- avoid contact with the eyes
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- do not use at the same time as other topical analgesics
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- do not apply to wounds or damaged skin
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- do not bandage tightly
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- do not use with heating pads or other heating devices
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- if you are pregnant or nursing, seek the advice of a health professional before using
Stop use and consult a doctor
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- condition worsens
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- symptoms persist for more than 7 days or clear up and occur again within a few days
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- redness is present
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- irritation develops
- Directions
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
MEIJER ANALGESIC WITH ALOE TOPICAL ANALGESIC
trolamine salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-418 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trolamine Salicylate (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) Trolamine Salicylate 100 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Cetyl Alcohol (UNII: 936JST6JCN) Glycerin (UNII: PDC6A3C0OX) Methylparaben (UNII: A2I8C7HI9T) Mineral Oil (UNII: T5L8T28FGP) POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) Propylparaben (UNII: Z8IX2SC1OH) Sodium Hydroxide (UNII: 55X04QC32I) Stearic Acid (UNII: 4ELV7Z65AP) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-418-01 1 in 1 CARTON 04/01/2019 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 04/01/2019 Labeler - Meijer Distribution, INC (006959555) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC. 255106239 MANUFACTURE(41250-418)