Afassco First Aid Burn Cream
FDA Label NDC 51532-4622

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Afassco First Aid Burn Cream (NDC 51532-4622). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active Ingredient

Benzalkonium Chloride  0.13%
Lidocaine HCL   0.5%

Otc - Purpose

Purpose  First aid antiseptic., external amalgesic

Indications & Usage

Uses

first aid to help prevent
infection and for the
temporary relief of pain and
itching associated with minor
cuts, scrapes, burns

Warnings

Warnings

For external use only

Do not use ■ in eyes ■ in

large quantities, over raw

blistered areas, on deep

puncture wounds, animal

bites or serious burns ■ for

more than one wek

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If ingested, contact a  Poison

Control Center right away.

Dosage & Administration

Directions 

■ clean affected area ■ apply

a small amount on area, not

more than 3 times daily

■ may cover with a sterile bandage

Other Safety Information

Other Information

store at room temperature

Inactive Ingredient

Inactive Ingredients

Peregal-O 2.5%, Glycerin

Monostearate 2.5%, Glycerol

5%, Purified Water

Package Label.Principal Display Panel

↓Principal Display 6 ct. Package↓

Afassco¦ ¦®

The First Choice

in First Aid

FIRST AID/BURN CREAM

No.339              6 ct.

6 ct.

FIRST AID/
BURN CREAM

ANSI Z308.1

Manufactured for Afassco, Inc., Minden, NV 89423

6 70254 20339 9

↓Principal Display 25 ct. Package↓

↓1 gm Packet↓

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