Coola Bare Hands Hand Sanitizer Gel

SPL v1

SPL

SPL Set ID a5ed2e88-2ecf-ddfd-e053-2995a90af914

Route

TOPICAL

Published

Effective Date 2020-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Calendula Officinalis Flower Chamomile Water Guaraprolose (1300 Mpa.s At 1%) Glycerin Aloe Vera Leaf Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-01

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

to help reduce bacteria on the skin

recommended for repeated use

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under age 6 should be supervised.

Warnings

For external use only

Flammable. Keep away from fire/flame.

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

Stop use and ask a doctor if irritation or rash appears and lasts.

Directions

Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinsing.

1.8 Fl Oz Bottle

Active Ingredient

Ethyl Alcohol 62%

Other Information

do not store above 104 F (40 C). May discolor certain fabrics or surfaces

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Hydroxypropyl Guar, Water

Structured Label Content

Uses

to help reduce bacteria on the skin

recommended for repeated use

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under age 6 should be supervised.

Purpose

Antiseptic

Warnings

For external use only

Flammable. Keep away from fire/flame.

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

Stop use and ask a doctor if irritation or rash appears and lasts.

Directions

Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinsing.

1.8 Fl Oz Bottle (1.8 fl oz bottle)

Active Ingredient

Ethyl Alcohol 62%

Other Information

do not store above 104 F (40 C). May discolor certain fabrics or surfaces

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Hydroxypropyl Guar, Water

Advanced Ingredient Data

[{"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUARAPROLOSE (1300 MPA.S AT 1%)", "unii": "1530WMS90S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to help reduce bacteria on the skin recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under age 6 should be supervised.", "Purpose": "Antiseptic", "Warnings": "For external use only Flammable. Keep away from fire/flame. Do not use product in/near the eyes. In case of eye contact, rinse thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.", "Directions": "Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinsing.", "Active Ingredient": "Ethyl Alcohol 62%", "Other Information": "do not store above 104 F (40 C). May discolor certain fabrics or surfaces", "Inactive Ingredients": "Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Hydroxypropyl Guar, Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:37.157335 · Updated: 2026-03-14T22:56:51.376724