CVS Health LUBRICANT EYE: Package Insert and Label Information

CVS HEALTH LUBRICANT EYE- mineral oil and petrolatum ointment
VELOCITY PHARMA LLC

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.

CVS health LUBRICANT EYE OINTMENT

Mineral oil 31.9%, White petrolatum 57.7%

Active ingredients

Mineral oil 31.9%

Purpose

Emollient

Active ingredients

White petrolatum 57.7%

Purpose

Emollient

Uses

  • temporarily relieves burning and irritation of the eye and discomfort due to dryness of the eye or exposure to wind or sun
  • as use as a protectant against further irritation

Warnings

For external use only

When using this product

  • to avoid contamination do not touch tip of container to any surface
  • replace cap after use

Stop use and ask a doctor if

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

1-800-222-1222

Directions

  • pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid

Other information

discard 30 days after opening. Retain this carton for future reference.

Inactive Ingredients

microcrystalline wax, stearic acid, wheat germ oil

PRINCIPAL DISPLAY PANEL

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CVS HEALTH LUBRICANT EYE
mineral oil and petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-707
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINERAL OIL (MINERAL OIL) MINERAL OIL 319 mg in 1 g
PETROLATUM (PETROLATUM) PETROLATUM 577 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE WAX
STEARIC ACID
WHEAT GERM OIL
Product Characteristics
Color white (Clear) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76168-707-35 1 TUBE in 1 BOX contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the BOX (76168-707-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 09/13/2021
Labeler — VELOCITY PHARMA LLC (962198409)
Establishment
Name Address ID/FEI Operations
BRASSICA PHARMA PRIVATE LIMITED 675476593 manufacture (76168-707)

Revised: 09/2021 VELOCITY PHARMA LLC

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