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Drug Facts
50% Rubbing Alcohol First Aid Antiseptic
FDA Label NDC 58037-702
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pride Products Corp. for the product 50% Rubbing Alcohol First Aid Antiseptic (NDC 58037-702). 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 - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Isopropyl alcohol (50% conc.)
Otc - Purpose
First aid antiseptic
Indications & Usage
USES
- first aid to help prevent the risk of infection in minor cuts, scrapes, and burns
- helps relieve minor muscular aches due to exertion
Warnings
Warnings
For external use only.
Flammable, keep away from heat, spark, electrical, fire or flame.
- helps relieve minor muscular aches due to exertion.
Otc - Do Not Use
Do not use
- in the eyes or apply over large areas of the body
- longer than 1 week
- do not inhale
Otc - Ask Doctor
Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns.
Otc - Stop Use
Stop use and ask a doctor if
- the condition persists or gets worse
- irritation, pain, or redness persists or worsens
- swelling, rash, or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- clean the affected area
- apply a small amount of product on the affected area 1 to 3 times a day
- may be covered with a sterile bandage
- if bandaged, let dry first
Other Safety Information
Other information
- keep tightly closed at controlled room temperature
- does not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredient
Purified water, methyl salicylate, FD&C Blue #1, FD&C Yellow #5.
Recent Major Changes
Incorrect heading selected
Package Label.Principal Display Panel
50% ISOPROPYL RUBBING ALCOHOL
First Aid Antiseptic
For Rubbing & Massaging
WINTERGREEN
Use only in a well ventilated area; fumes may be harmful.
CAUTION: Do not point at self or others; product will squirt when squeezed.
WARNING: FLAMMABLE
KEEP AWAY FROM HEAT, SPARK, ELECTRICAL, FIRE OR FLAME
12 FL OZ (355 mL)
Alcohol's effectiveness at killing germs *drops sharply when diluted below 50% concentration, *and the optimal concentration for killing bacteria is between 60 to 90 percent, according to CDC. For hand sanitization purposes, a 70% dilution is recommended. *This product is intended for massaging, minor cuts and other cleaning purposes.
Manufactured for:
NEW PRIDE CORP.
RONKONKOMA, NY 11779
prideproducts.com
A PROUD AMERICAN COMPANY
Made in Jordan
* Please review the disclaimer below.
