MOISTU-EYES- white petrolatum, mineral oil ointment

MOISTU-EYES by

Drug Labeling and Warnings

MOISTU-EYES by is a Otc medication manufactured, distributed, or labeled by BRASSICA PHARMA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Ingredients:

White Petrolatum 57.3%

Mineral Oil 42.5%

Purpose

Lubricating Emollient

Uses:

• To lubricate and protect your eyes in certain eye conditions, or during or after surgery.

Warning

• For external use only.
• Do not use if you are allergic to Lanolin Alcohols or any of the other ingredients of MOISTU-EYES ®.
• May cause short-term blurring (typically 1-15 minutes upon use).

Do not drive or use machinery unless your vision is clear.

Stop use and ask a doctor if

you experience any of the following, stop use and see your doctor: eye pain, eye irritation, eye redness, eye itching, swelling of the eyelid, increased tear production, feeling there's something in your eye, hypersensitivity (allergic reaction).

KEEP OUT OF REACH OF CHILDREN

Keep out of reach and sight of children.

Directions:

• Pull lower lid down to form a pouch and apply a small strip of ointment to it.
• Repeat this treatment as often as needed or as directed by your doctor. If you get any side effects, talk to your doctor, pharmacist or nurse.

Other Information

• Remove contact lenses before use. After use, wait 30 minutes before putting them back in.
• Do not use after the expiry date shown.
• Discard any unused product 1 month after first opening.
• Store below 25°C.

Inactive Ingredients:

Lanolin Alcohols.

Question or Comments:

Call: +912228704581

SPL UNCLASSIFIED SECTION

Eye Ointment
Preservative Free

STERILE

Eye Lubricant
For External Use

Moistueyes ® is used to lubricate and protect your eyes in certain eye conditions, or during or after surgery.

Distributed by:
Amilco Ltd, Mckenzie House, Bury Street, Ruislip, HA4 7TL, UK

Manufactured by:
Brassica Pharma Private Limited,
Plot No.T-68, T-68 (PT) & T-63, M.I.D.C., Tarapur, (W), Boisar - Thane-401 502 India. (IND)

Packaging

INGREDIENTS AND APPEARANCE

MOISTU-EYES 
white petrolatum, mineral oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72362-101
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	57.3 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	42.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Product Characteristics
Color	white (Off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72362-101-01	1 in 1 CARTON	06/11/2018
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72362-101-02	1 in 1 CARTON	06/11/2018
2		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/11/2018

Labeler - BRASSICA PHARMA PRIVATE LIMITED (675476593)

Establishment
Name	Address	ID/FEI	Business Operations
BRASSICA PHARMA PRIVATE LIMITED		675476593	manufacture(72362-101)