Archie's Dry Eye Relief 30ct & 60ct (pld)

Archie's Dry Eye Relief 30ct & 60ct (pld)
SPL v3
SPL
SPL Set ID 07da099b-6b7f-984d-e063-6294a90a12ac
Route
OPHTHALMIC
Published
Effective Date 2023-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (0.4 g) Propylene Glycol (0.3 g)
Inactive Ingredients
Potassium Chloride Water Hydrochloric Acid Sodium Chloride Hypromellose, Unspecified Sodium Hydroxide Boric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-16

Description

Polyethylene glycol 400 0.4% Propylene glycol 0.3%

Purpose

Lubricant Lubricant


Medication Information

Purpose

Lubricant Lubricant

Description

Polyethylene glycol 400 0.4% Propylene glycol 0.3%

Use
  • for the temporary relief of burning and irritation of the eye due to dryness of the eye
Purposes

Lubricant

Lubricant

Warnings

For external use only

Directions
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Other Information
  • store at 15°-25°C (59°-77°F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
Active Ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Inactive Ingredients

boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

When Using This Product
  • to avoid contamination, do not touch tip of container to any surface.
  • do not reuse. Once opened, discard.
Archie's Dry Eye Relief 30ct

Archie's Dry Eye Relief 60ct

Stop Use and Ask A Doctor If
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use
  • for the temporary relief of burning and irritation of the eye due to dryness of the eye
Purposes

Lubricant

Lubricant

Warnings

For external use only

Directions
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Other Information (Other information)
  • store at 15°-25°C (59°-77°F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
Active Ingredients (Active ingredients)

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Inactive Ingredients (Inactive ingredients)

boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

When Using This Product (When using this product)
  • to avoid contamination, do not touch tip of container to any surface.
  • do not reuse. Once opened, discard.
Archie's Dry Eye Relief 30ct

Archie's Dry Eye Relief 60ct

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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