SPL v2
SPL
SPL Set ID 0d666752-4e30-46e4-a155-d239713cfcb5
Route
TOPICAL
Published
Effective Date 2015-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Carbomer Copolymer Type A Trolamine Glycerin Propylene Glycol Aloe Vera Leaf Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-02-17
Description

Active Ingredient                          Purpose Ethyl Alcohol 62.0% ................. Antimicrobial

Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Indications and Usage

XtraCare®

Kills 99.9% of germs

Instant Hand Sanitizer

with moisturizers

cucumber melon scent

8 FL OZ / 237 mL

Dosage and Administration

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product
Description

Active Ingredient                          Purpose Ethyl Alcohol 62.0% ................. Antimicrobial

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, fd&c blue no. 1, fd&c red no.33

Section 51945-4

Section 55105-1

Uses

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Section 55106-9

Active Ingredient                          Purpose

Ethyl Alcohol 62.0% ................. Antimicrobial

Structured Label Content

Indications and Usage (34067-9)

XtraCare®

Kills 99.9% of germs

Instant Hand Sanitizer

with moisturizers

cucumber melon scent

8 FL OZ / 237 mL

Dosage and Administration (34068-7)

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product
Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, fd&c blue no. 1, fd&c red no.33

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Section 55106-9 (55106-9)

Active Ingredient                          Purpose

Ethyl Alcohol 62.0% ................. Antimicrobial

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.632986 · Updated: 2026-03-14T22:55:37.343071