SK Maximum Redness Relief

SK Maximum Redness Relief by

Drug Labeling and Warnings

SK Maximum Redness Relief by is a Otc medication manufactured, distributed, or labeled by Synpac-Kingdom Pharmaceuticals, Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SK MAXIMUM REDNESS RELIEF- naphazoline hydrochloride and glycerin liquid 
Synpac-Kingdom Pharmaceuticals, Co., Ltd.

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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SK Maximum Redness Relief

Drug Facts

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

Purpose

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 the dryness of the eye.
  
• for the use as a protectant against further irritation or dryness of the eye.

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

Ask a doctor before use if you have

narrow angle glaucoma

When using this product

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

Stop use andask a doctor if you experience

• eye pain
• changes in vision
• continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions

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

Other information

• Store at room temperature
• Remove contact lens before using

Inactive ingredients

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

Principal Display Panel

SK MAXIMUM
REDNESS RELIEF
STERILE 0.5 FL OZ (15 mL)

SK MAXIMUM REDNESS RELIEF 
naphazoline hydrochloride and glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81772-002
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.3 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 mg  in 1 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: 81772-002-01	1 in 1 CARTON	06/29/2021	12/31/2021
1		15 mL in 1 BOTTLE, DROPPER; 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	06/29/2021	12/31/2021

Labeler - Synpac-Kingdom Pharmaceuticals, Co., Ltd. (657636332)

Revised: 10/2022

Document Id: eab81c33-d9e2-4847-ac53-b76566bcf866

34390-5

Set id: a82cb5be-c47f-4901-ace1-0c5b70016863

Version: 2

Effective Time: 20221031

 

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