Label: FIRST AID DIRECT INDUSTRIAL EYE DROPS- sterile industrial eye drops solution/ drops
- NDC Code(s): 42961-219-01, 42961-219-02
- Packager: Cintas Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 1, 2022
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- Active ingredients
- Purposes
- Uses
- Warnings
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions?
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Bottle Label - 42961-219-01
Distributed by:
First Aid Direct, Mason, OH 45040 #130200 (7/19)Sterile Industrial Eye Drops
Lubricant Redness Reliever
Helps Relieve Irritation and Redness
Individual Use
Do not use if imprinted safety seal is broken or missing.
1/2 fl oz (15 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED NECKBAND IS MISSING OR BROKEN.
KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Active ingredients
Glycerin 0.25%
Naphazoline HCI 0.012%
Purposes
Lubricant
Redness reliever
Uses
- for the relief of redness of the eye due to minor eye irritations
- for the temporary relief of burning and irritation due to dryness of the eye
- for use as a protectant against further irritation or dryness of the eye.
Warnings
For external use only.
Directions
instill 1 to 2 drops in the affected eye(s) up to 4 times daily
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate
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Box Label - 42961-219-02
Sterile Industrial Eye Drops
Lubricant Redness Reliever
Helps Relieve Irritation and Redness
Individual Use
Do not use if imprinted safety seal is broken or missing.
1/2 fl oz (15 mL)
*This product is not manufacturered or distributed by Prestige Brands, Inc. owner of the registred trademark Clear Eyes®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED NECKBAND IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Sterile Industrial Eye Drops Product #130200
Distributed by: First Aid Direct, Mason, OH 45040
#130200 (7/19)
(7/19) #130200
LOT EXP
Sterile Industrial Eye Drops 130200
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INGREDIENTS AND APPEARANCE
FIRST AID DIRECT INDUSTRIAL EYE DROPS
sterile industrial eye drops solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-219 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2.5 mg in 100 mL NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.132 mg in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-219-02 1 in 1 BOX 12/15/2022 1 NDC:42961-219-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 01/28/2022 Labeler - Cintas Corp (056481716) Establishment Name Address ID/FEI Business Operations KC Pharmaceuticals 174450460 manufacture(42961-219)