A-MED BRAND FIRST AID EYE AND SKIN-RINSE- purified water solution

A-Med brand First Aid Eye and Skin-Rinse by

Drug Labeling and Warnings

A-Med brand First Aid Eye and Skin-Rinse by is a Otc medication manufactured, distributed, or labeled by Oliver Landon Intl Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Purified water USP 98.577% w/v

Purpose

Eyewash

First Aid Eye Rinse Use

Use for flushing the eye to reduce chances of severe injury caused by acid, alkali or particulate contamination.

Eyewash Use

Use for flushing the eye to remove loose foreign material.

Warnings

For external use only

• To avoid contamination, do not touch tip of container to any surface.
• Do not reuse.
• Once opened, discard.
• If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor.
• Obtain immediate medical treatment for all open wounds in or near the eyes.
• If solution changes color or becomes cloudy do not use; nor, if twist-off Tamper Evident top is broken or missing.

Keep out of reach of children

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

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other information

• Store out of direct sunlight
• at 2° - 40°C (36° - 104°F)
• Use at 15° - 30°C (59° - 86°F)

Inactive ingredients

Disodium EDTA, Sodium Chloride, Sodium Phosphate Dibasic dodecahydrate, Sodium Phosphate, Monobasic dihydrate, Sodium Hydroxide may be used to adjust pH. PRESERVATIVE added: Polyhexanide 0.0001%

Questions and Comments

Email: info@oliverlandon.biz

SPL UNCLASSIFIED SECTION

Oliver Landon Intl Inc.

The Grove 21 Pine Road

Belleville, St. Michael,
BB 11113
Barbados
info@OliverLandon.biz

Package/Label Principal Display Panel

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

A-MED BRAND FIRST AID EYE AND SKIN-RINSE 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59276-209
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.577 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLIHEXANIDE (UNII: 322U039GMF)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59276-209-12	5 in 1 BOX	11/01/2013
1	NDC: 59276-209-10	15 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 59276-209-14	10 in 1 BOX	11/01/2013
2	NDC: 59276-209-10	15 mL in 1 VIAL; Type 0: Not a Combination Product
3	NDC: 59276-209-16	30 in 1 BOX	11/01/2013
3	NDC: 59276-209-10	15 mL in 1 VIAL; Type 0: Not a Combination Product
4	NDC: 59276-209-18	60 in 1 BOX	11/01/2013
4	NDC: 59276-209-10	15 mL in 1 VIAL; Type 0: Not a Combination Product
5	NDC: 59276-209-21	4 in 1 BOX	11/01/2013
5	NDC: 59276-209-20	30 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
6	NDC: 59276-209-31	1 in 1 BOX	11/01/2013
6	NDC: 59276-209-30	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 59276-209-41	1 in 1 BOX	11/01/2013
7	NDC: 59276-209-40	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
8	NDC: 59276-209-51	1 in 1 BOX	11/01/2013
8	NDC: 59276-209-50	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9	NDC: 59276-209-61	1 in 1 BOX	11/01/2013
9	NDC: 59276-209-60	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10	NDC: 59276-209-71	1 in 1 BOX	11/01/2013
10	NDC: 59276-209-70	350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
11	NDC: 59276-209-81	1 in 1 BOX	11/01/2013
11	NDC: 59276-209-80	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12	NDC: 59276-209-82	2 in 1 BOX	11/01/2013
12	NDC: 59276-209-80	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13	NDC: 59276-209-91	1 in 1 BOX	11/01/2013
13	NDC: 59276-209-90	947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14	NDC: 59276-209-92	2 in 1 BOX	11/01/2013
14	NDC: 59276-209-90	947 mL in 1 BOTTLE, PLASTIC; 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	11/01/2013

Labeler - Oliver Landon Intl Inc. (815240195)