Label: MODEL AA-1218CEV- kit
- NHRIC Code(s): 27860-010-11
- Packager: Aerospace Accessory Service, Inc
- This is a repackaged label.
- Source NDC Code(s): 65785-160
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated May 5, 2021
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- Aerospace Accessory Service
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INGREDIENTS AND APPEARANCE
MODEL AA-1218CEV
first aid kit with drug kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:27860-010 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:27860-010-11 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 3 1 Part 4 1 Part 5 1 Part 6 1 Part 7 1 Part 8 1 Part 9 1 Part 10 1 Part 11 1 Part 1 of 11 MOORE MEDICAL NON ASPIRIN
acetaminophen tablet, film coatedProduct Information Item Code (Source) NDC:55670-467 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code AZ;234 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 Part 2 of 11 MOORE MEDICAL ANTACID
calcium carbonate tablet, chewableProduct Information Item Code (Source) NDC:55670-142 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 420 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor MINT (MINT) Imprint Code FR;8 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/30/2008 Part 3 of 11 AMMONIA INHALANTS
ammonia inhalants inhalantProduct Information Item Code (Source) NDC:46414-3333 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/14/1976 Part 4 of 11 EASY CARE FIRST AID DIPHENHYDRAMINE
diphenhydramine hydrochloride tablet, film coatedProduct Information Item Code (Source) NDC:44224-0017 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink (pink) Score no score Shape OVAL (OVAL) Size 11mm Flavor Imprint Code 048;D Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2012 Part 5 of 11 BZK PADS
benzalkonium chloride swabProduct Information Item Code (Source) NDC:67777-245 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/05/2011 Part 6 of 11 POVIDONE-IODINE
povidone-iodine solutionProduct Information Item Code (Source) NDC:46414-7777 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/14/1976 Part 7 of 11 MOORE MEDICAL BISMUTH
bismuth subsalicylate tablet, chewableProduct Information Item Code (Source) NDC:55670-474 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) MALTODEXTRIN (UNII: 7CVR7L4A2D) ASPARTAME (UNII: Z0H242BBR1) CALCIUM CARBONATE (UNII: H0G9379FGK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor Imprint Code RH;046 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 04/01/2014 Part 8 of 11 MOOREBRAND PHENYLEPHRINE
phenylephrine hydrochloride tablet, film coatedProduct Information Item Code (Source) NDC:55670-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red (red) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 271 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 Part 9 of 11 STYE
mineral oil and petrolatum gelProduct Information Item Code (Source) NDC:63736-238 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 319 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 577 mg in 1 g Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) WHEAT GERM OIL (UNII: 14C97E680P) Product Characteristics Color white (Clear) Score Shape Size Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 06/15/2010 Part 10 of 11 ANTIMICROBIAL
alcohol liquidProduct Information Item Code (Source) NDC:61010-3111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol 665 mL in 1 L Inactive Ingredients Ingredient Name Strength aloe (UNII: V5VD430YW9) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/21/2012 Part 11 of 11 PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH
purified water 98.3% solutionProduct Information Item Code (Source) NDC:0924-0160(NDC:65785-160) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 929 g in 946 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022305 06/12/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date exempt device ABC 01/01/2015 Labeler - Aerospace Accessory Service, Inc (859100547) Registrant - Aerospace Accessory Service, Inc (859100547) Establishment Name Address ID/FEI Business Operations Aerospace Accessory Service, Inc 859100547 manufacture, repack