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NDC 48878-0231-07 Avagard D 530.7 mg/mL Details

Avagard D 530.7 mg/mL

Avagard D is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by 3M ESPE Dental Products. The primary component is ALCOHOL.

Product Information

NDC	48878-0231
Product ID	48878-0231_9a6c41a2-f87f-42b4-84e1-6509920f7330
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Avagard D
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	530.7
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	3M ESPE Dental Products
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 48878-0231-07 (48878023107)

Pricing Information	N/A
NDC Package Code	48878-0231-7
Billing NDC	48878023107
Package	12 BOTTLE in 1 CASE (48878-0231-7) / 500 mL in 1 BOTTLE
Marketing Start Date	2011-04-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 00c56d8d-02e6-4839-86cc-00767428d5e9 Details

Active Ingredient

Ethyl Alcohol, 61% w/w

Purpose

Antiseptic

Uses

instant healthcare personnel hand antiseptic

reduces bacteria that potentially can cause disease
recommended for repeated use

Warnings

Flammable, keep away from fire or flame.

For external use only

When using this product

Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation, or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to clean, dry hands. Wet hands thoroughly with product and allow to dry.

Other information

Store at 20-25°C (68-77°F)

Inactive ingredient

beheneth-10, behenyl alcohol, C20-40 pareth-24, cetyl palmitate, diisopropyl dimer dilinoleate, dimethicone, glycerin, polyethylene glycol, squalane, water

Principal Display Panel

NDC 48878-0231-7

3M ESPE

Avagard™ D

Instant Hand Antiseptic

With Moisturizers

Contains: 61% w/w ethyl alcohol

Destroys Bacteria. Not Your Skin.

Flammable, keep away from fire or flame, heat,

sparks and sources of static discharge.

REF 2317

500 ml • 16fl oz

INGREDIENTS AND APPEARANCE

AVAGARD D

alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48878-0231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	530.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Beheneth-10 (UNII: 313S43DM16)
Docosanol (UNII: 9G1OE216XY)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol, unspecified (UNII: 3WJQ0SDW1A)
Squalane (UNII: GW89575KF9)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:48878-0231-7	12 in 1 CASE	04/28/2011
1		500 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/01/1999

Labeler - 3M ESPE Dental Products (801390852)

Revised: 11/2021

Document Id: 9a6c41a2-f87f-42b4-84e1-6509920f7330

Set id: 00c56d8d-02e6-4839-86cc-00767428d5e9

Version: 7

Effective Time: 20211115