Label: COATS ALOE ANALGESIC- methyl salicylate, aloe lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58826-704-08, 58826-704-33 - Packager: TYCHASIS CORPORATION
- 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 October 5, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- USE
- PURPOSE
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WARNINGS
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES
DO NOT APPLY TO WOUNDS OR DAMAGED SKIN WITH A HEATING PAD
DISCONTINUE IF IRRITATION DEVELOPS
DO NOT USE IN COMBINATION WITH OTHER ANALGESIC PRODUCTS
WASH HANDS WITH SOAP AND WATER AFTER USE
DO NOT BANDAGE TIGHTLY
STOP USE AND ASK DOCTOR IF CONDITION WORSENS IF SYMPTOMS PERSIST MORE THAN 7 DAYS, OR IF SYMPTOMS WORSEN WITHIN A FEW DAYS.
NOT RECOMMENDED IF YOU ARE PREGNANT OR BREASTFEEDING. CONSULT YOUR PHYSICIAN.
KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED SEEK MEDICAL HELP OR CONTACT POISON CONTROL IMMEDIATELY.
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
Aloe Barbadenesis Leaf Juice, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Disodium EDTA, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Isododecane, Isopentylidiol, Menthol, Pentylene Glycol, Petrolatum, Phenoxyethanol, Potassium palmitol hyrdrolyzed wheat protein, Prunus Armeniaca (Apricot Kernel Oil), Sodium Hyrdroxide, Water (Aqua)
- KEEP OUT OF REACH OF CHILDREN
- PACKAGE LABEL COATS ALOE LINIMENT 8 OZ
- QUESTIONS
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INGREDIENTS AND APPEARANCE
COATS ALOE ANALGESIC
methyl salicylate, aloe lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58826-704 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 g in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ISODODECANE (UNII: A8289P68Y2) ISOPENTYLDIOL (UNII: 19NOL5474Q) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) PRUNUS ARMENIACA SEED (UNII: 75356789IW) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MENTHOL (UNII: L7T10EIP3A) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58826-704-08 237 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/29/2015 2 NDC:58826-704-33 976 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/29/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/29/2015 Labeler - TYCHASIS CORPORATION (022731149)
