DG Maximum Strength Redness Relief: Package Insert and Label Information

DG MAXIMUM STRENGTH REDNESS RELIEF- glycerin and naphazoline hydrochloride solution
Dolgencorp, 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.

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

Purposes

Glycerin —-Lubricant

Naphazoline hydrochloride —-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

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

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

Inactive ingredients

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

DG MAXIMUM STRENGTH REDNESS RELIEF glycerin, naphazoline hcl solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-870 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 0.5 g in 100 mL NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.03 g in 100 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID SODIUM BORATE BENZALKONIUM CHLORIDE WATER EDETATE DISODIUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-870-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER 1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (55910-870-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 01/31/2020

Labeler — Dolgencorp, Inc (068331990)

Registrant — K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture (55910-870), pack (55910-870), label (55910-870)

Revised: 12/2022 Dolgencorp, Inc