ROHTO DRY-AID- povidone, propylene glycol liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E), PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)
Available from:
The Mentholatum Company
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Povidone – Lubricant Propylene glycol - Lubricant
Authorization status:
OTC monograph final
Authorization number:
10742-8162-1, 10742-8162-2

ROHTO DRY-AID- povidone, propylene glycol liquid

The Mentholatum Company

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.

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Drug Facts

Active ingredient

Povidone 0.68%

Propylene glycol 0.3%

Purpos e

Povidone – Lubricant

Propylene glycol - Lubricant

Us es

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

temporarily relieves burning and irritation due to dryness of the eye

protects against further irritation or to relieve dryness of the eye

do not touch tip of container to any surface to avoid contamination

replace cap after each use

do not use if solution changes color or becomes cloudy

remove contact lenses before using

you feel eye pain

changes in vision occur

redness or irritation of the eyes lasts

condition worsens or lasts more than 72 hours

put 1 or 2 drops in the affected eye(s) as needed

tightly snap on cap to seal

Other information

Inactive ingredients

boric acid, calcium chloride, edetate disodium, magnesium sulfate, menthol, PEG-10 castor oil,

poloxamer, polyaminopropyl biguanide, polyoxyl stearate, purified water, sesame oil, sodium borate

Ques tions ?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Principal Display Panel

ROHTO DRY-AID

povidone, propylene glycol liquid

Product Information

do not freeze

The Mentholatum Company

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 742-8 16 2

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E) (POVIDONE, UNSPECIFIED -

UNII:FZ9 8 9 GH9 4E)

POVIDONE,

UNSPECIFIED

6 .8 mg

in 1 mL

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) (PROPYLENE GLYCOL - UNII:6 DC9 Q16 7V3)

PROPYLENE GLYCOL

3 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BO RIC ACID (UNII: R57ZHV8 5D4)

CALCIUM CHLO RIDE (UNII: M4I0 D6 VV5M)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

MAGNESIUM SULFATE ANHYDRO US (UNII: ML30 MJ2U7I)

RACEMENTHO L (UNII: YS0 8 XHA8 6 0 )

PO LYO XYL 3 5 CASTO R O IL (UNII: 6 D4M1DAL6 O)

PEG/PPG-10 5/5 CO PO LYMER (UNII: 529 0 1V8 XAR)

PO LIHEXANIDE HYDRO CHLO RIDE (UNII: 4XI6 11249 6 )

PO LYO XYL 4 0 STEARATE (UNII: 13A4J4NH9 I)

WATER (UNII: 0 59 QF0 KO0 R)

SESAME O IL (UNII: QX10 HYY4QV)

SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:10 742-8 16 2-

1 in 1 CARTON

0 1/0 1/20 17

1

10 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:10 742-8 16 2-

2 in 1 CARTON

0 1/0 1/20 17

2

10 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

0 1/0 1/20 17

Labeler -

T he Mentholatum Company (002105757)

Revised: 3/2020

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