Label: FIRST AID ONLY STING RELIEF PAD- benzocaine, isopropyl alcohol liquid
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NDC Code(s):
0924-5204-01,
0924-5204-02,
0924-5204-03,
0924-5204-04, view more0924-5204-05
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 59050-414
- 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 February 3, 2022
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- Drug Facts
- Active ingredients
- INDICATIONS & USAGE
- Warnings
- Directions
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY STING RELIEF PAD
benzocaine, isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5204(NDC:59050-414) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 60 mg in 1 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 600 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-5204-05 100 in 1 BOX 02/25/2022 1 0.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:0924-5204-04 50 in 1 BOX 02/25/2022 2 0.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:0924-5204-03 25 in 1 BOX 02/25/2022 3 0.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 4 NDC:0924-5204-02 10 in 1 BOX 02/25/2022 4 0.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 5 NDC:0924-5204-01 0.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 02/25/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/25/2022 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-5204) , repack(0924-5204) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-5204) , repack(0924-5204) Establishment Name Address ID/FEI Business Operations Acme United Corporation 117825595 manufacture(0924-5204)