SUNMARK REDNESS RELIEF- glycerin, naphazoline hydrochloride liquid 
Strategic Sourcing Services LLC

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.

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Sunmark Redness Relief (PLD)

Active Ingredients

Glycerin 0.2%

Naphazoline hydrochloride 0.012%

Purpose

Lubricant and redness reliver

Uses

  • relieves redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • temporarily relieves burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use this product if

  • solution changes color or become cloudy

Ask a doctor before use

if you have narrow angle glaucoma

when using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
  • overuse may cause more redness of the eye
  • pupils may become enlarged temporarily

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens
  • symptoms last for more than 72 hours

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information

  • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Carton

SUNMARK REDNESS RELIEF 
glycerin, naphazoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-894
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.012 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-894-291 in 1 CARTON10/01/200912/13/2022
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/01/200912/13/2022
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(49348-894) , pack(49348-894) , label(49348-894)

Revised: 12/2022
Document Id: efb8b41e-52b3-2c68-e053-2995a90ae9e5
Set id: 47fc9b82-6920-4bee-a34d-2658ddee6ca3
Version: 4
Effective Time: 20221213
 
Strategic Sourcing Services LLC