DG MAXIMUM STRENGTH REDNESS RELIEF- glycerin, naphazoline hcl solution 
K.C. Pharmaceuticals, Inc.

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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DG Health Maximum Strength Redness Relief

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

Purposes

Glycerin ----Lubricant

Naphazoline hydrochloride ----Redness reliever

Uses

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

  • To avoid contamination, do not touch tip of container to any surface
  • Replace cap after using
  • Overuse may produce increased redness of the eye
  • Pupils may become enlarged temporarily

Stop use and ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • 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.

Directions

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

Other information

Inactive ingredients

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

Package Label

DG MAXIMUM STRENGTH REDNESS RELIEF 
glycerin, naphazoline hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-870
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.03 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55651-870-011 in 1 CARTON01/31/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/31/2020
Labeler - K.C. Pharmaceuticals, Inc. (174450460)
Registrant - K.C. Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
K.C. Pharmaceuticals, Inc.174450460manufacture(55651-870) , pack(55651-870) , label(55651-870)

Revised: 12/2022
Document Id: efe45218-4dd7-1baa-e053-2995a90a004b
Set id: d329be9c-9ea8-2306-e053-2995a90a77ee
Version: 2
Effective Time: 20221215
 
K.C. Pharmaceuticals, Inc.