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FDA Approval

70%

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 21, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Isopropyl alcohol(70 mL in 100 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Consumer Product Partners, LLC

119091520

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Consumer Product Partners, LLC

Retail Business Services, LLC

Consumer Product Partners, LLC

119091514

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

70%

Product Details

NDC Product Code
72476-810
Application Number
M003
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 21, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: ND2M416302Class: ACTIBQuantity: 70 mL in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panel

CAREONE ®

70% Isopropyl Alcohol

First Aid Antiseptic

For Rubbing and Massaging

Isopropyl Alcohol 70%

WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame

CAUTION: Do not point at self or others; product will squirt when squeezed.

Use only in a well-bentilated area; fumes can be harmful

OUR PHARMACISTS RECOMMEND

16 FL OZ (473 mL)

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INDICATIONS & USAGE SECTION

Use

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area
  • apply a small amount of this product on the affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

WARNINGS SECTION

Warnings

For external use only.If taken internally serious gastric disturbances will result.

Flammable- Keep away from fire or flame, heat, spark, electrical


ADVERSE REACTIONS SECTION

ADVERSE REACTION

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 1-877-846-9949

©2016 S&S BRANDS, LLC

Quality Guaranteed or your money back.

Pat. D675,101


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Isopropyl alcohol 70%

OTC - PURPOSE SECTION

purpose

First Aid Antiseptic

OTC - ASK DOCTOR SECTION

Ask a Doctor before use

for deep or puncture wounds, animal bites or serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

OTC - STOP USE SECTION

Stop use and ask a doctor

If condition persists or gets worse

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes
  • do not inhale
  • do not apply over large areas of the body
  • do not use longer than 1 week

SPL UNCLASSIFIED SECTION

Caution

Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

OTHER SAFETY INFORMATION

Other information

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

INACTIVE INGREDIENT SECTION

Inactive ingredients

water


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