NDC 72570-129 Cry For You Lubricant Eye Drops

Glycerin, Hypromellose, Polyethylene Glycol 400

NDC Product Code 72570-129

NDC 72570-129-15

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Cry For You Lubricant Eye Drops with NDC 72570-129 is a a human over the counter drug product labeled by Delsam Pharma Llc. The generic name of Cry For You Lubricant Eye Drops is glycerin, hypromellose, polyethylene glycol 400. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Delsam Pharma Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cry For You Lubricant Eye Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 2 mg/mL
  • HYPROMELLOSE, UNSPECIFIED 3.6 mg/mL
  • POLYETHYLENE GLYCOL 400 10 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Delsam Pharma Llc
Labeler Code: 72570
FDA Application Number: part349 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cry For You Lubricant Eye Drops Product Label Images

Cry For You Lubricant Eye Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Glycerin 0.2%Hypromellose 0.36%Polyethylene glycol 400 1%

Purpose

Lubricant

Uses

• For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun• For protection against further irritation

Warnings

For external use only.• Remove contact lenses before using• Do not use if this solution changes color or becomes cloudy.• do not touch tip of container to any surface to avoid contamination• replace cap after each useStop use and ask a doctor if• You feel eye pain,• Changes in vision occur• Redness or irritation of the eye lasts• Condition worsens or lasts more than 72 hours.If pregnant of 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 right away.

Directions

• Put 1 or 2 drops in the affected eye(s) as needed• Children under 6 years of age : ask a doctor

Other Information

Store at 15°C to 25° (59° to 77°F)

Inactive Ingredients

Ascorbic acid, Dextrose, Magnesium chloride, Potassium chloride, Sodium citrate, Sodium chloride, Water for injection

Questions?

1-866-826-1306, between 11:00 AM to 4 PM EST, Monday to Friday (or) mail to [email protected]

* Please review the disclaimer below.