ANTISEPTIC- isopropyl alcohol liquid

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by ReliaMed, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Isopropyl Alcohol 71.5%

Purpose

Antiseptic

Uses

For preparation of the skin prior to injection or venipuncture

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use with electrocautery procedures or in or near the eyes. For external use only.

Stop use and ask a doctor if irritation or redness develop and 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.

Directions

• clean the area
• start at the venipuncture site and apply in a circular fashion using friction

Inactive ingredients

purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol SDA-40B, acetyl tributyl citrate, chloroxylenol

PRINCIPAL DISPLAY PANEL – packet label

REORDER NO. ZA50075

LATEX FREE

NDC: 52641-700-02

ReliaMed

I.V.
Antiseptic Wipes

For preparation of the skin prior
to injection or venipuncture

Contains: One Wipe

Distributed by ReliaMed

Ft. Worth, TX 76106 1-800-409-2848

Made in the U.S.A. Rev 050611

TEAR HERE

PRINCIPAL DISPLAY PANEL – box label

NEW

ReliaMed

REORDER NO. ZA50075

LATEX FREE

NDC: 52641-700-02

I.V. Antiseptic Wipes

For preparation of the skin prior to injection or venipuncture

75 Individual Wipes

• Protect skin from adhesives
• Non-irritating to intact skin
• Thick, soft application pad
  

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52641-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302)	isopropyl alcohol	0.56118 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)
acetyltributyl citrate (UNII: 0ZBX0N59RZ)
chloroxylenol (UNII: 0F32U78V2Q)
ethyl nitrate (UNII: E1ZT886LR5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52641-700-02	75 in 1 BOX	06/23/2011
1		1.2 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 52641-700-01	50 in 1 BOX	06/23/2011
2		1.2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2011

Labeler - ReliaMed (049386139)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(52641-700)