Hand Sanitizer

SPL v1

SPL

SPL Set ID a3356620-3c52-03a2-e053-2a95a90a8561

Route

TOPICAL

Published

Effective Date 2020-04-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.053 g)

Inactive Ingredients

Limonene, (+)- Aloe Vera Leaf Polysaccharides Glycerin Water Hydroxypropyl Cellulose, Unspecified

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing: a. USP/FCC grade Isopropyl alcohol (70% v/v) b. Distilled/purified water c. Hydroxypropylcellulose (as Vegetable Cellulose) d. Glycerin USP/FCC grade e. Limonene (as fragrance) f. Aloe Vera extract Hand Sanitizer Label:

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Uses

Decreases bacteria on skin.

Section 42229-5

This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing:

a. USP/FCC grade Isopropyl alcohol (70% v/v)

b. Distilled/purified water

c. Hydroxypropylcellulose (as Vegetable Cellulose)

d. Glycerin USP/FCC grade

e. Limonene (as fragrance)

f. Aloe Vera extract

Hand Sanitizer Label:

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use

Stop use and ask doctor if irritation and redness develop.

Warnings

For external use only. Flammable, keep away from flames.

Questions

Questions? Call 1-385-244-0470 Monday

through Friday 8:30 AM to 5:00 PM MST.

Directions

• Rub hands thoroughly with product and allow to dry.

• For children under 6, use only under adult supervision.

Other Information

• Store below 110ºF (43ºC).

• May discolor certain fabrics or surfaces.

Active Ingredient(s)

Isopropyl alcohol 70%

Inactive Ingredients

Inactive ingredients Distilled Water,

Structured Silver, Vegetable Cellulose,

Glycerin, Aloe Vera, Fragrance.

When Using This Product

When using this product keep out of eyes. In case of contact, flush eyes with water.

Package Label Principal Display Panel

2 FL OZ (59.15 mL) NDC: 75270-001-02

Structured Label Content

Uses

Decreases bacteria on skin.

Section 42229-5 (42229-5)

This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing:

a. USP/FCC grade Isopropyl alcohol (70% v/v)

b. Distilled/purified water

c. Hydroxypropylcellulose (as Vegetable Cellulose)

d. Glycerin USP/FCC grade

e. Limonene (as fragrance)

f. Aloe Vera extract

Hand Sanitizer Label:

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic, Hand Sanitizer

Stop Use (Stop use)

Stop use and ask doctor if irritation and redness develop.

Warnings

For external use only. Flammable, keep away from flames.

Questions

Questions? Call 1-385-244-0470 Monday

through Friday 8:30 AM to 5:00 PM MST.

Directions

• Rub hands thoroughly with product and allow to dry.

• For children under 6, use only under adult supervision.

Other Information (Other information)

• Store below 110ºF (43ºC).

• May discolor certain fabrics or surfaces.

Active Ingredient(s)

Isopropyl alcohol 70%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients Distilled Water,

Structured Silver, Vegetable Cellulose,

Glycerin, Aloe Vera, Fragrance.

When Using This Product (When using this product)

When using this product keep out of eyes. In case of contact, flush eyes with water.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

2 FL OZ (59.15 mL) NDC: 75270-001-02

Advanced Ingredient Data

[{"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "0.053", "strengthDenominator": "52.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF POLYSACCHARIDES", "unii": "W21O437517", "classCode": "IACT", "strengthNumerator": "0.053", "strengthDenominator": "52.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.368", "strengthDenominator": "52.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "14.04", "strengthDenominator": "52.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "37.34", "strengthDenominator": "52.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "0.736", "strengthDenominator": "52.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Decreases bacteria on skin.", "42229-5": "This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing: a. USP/FCC grade Isopropyl alcohol (70% v/v) b. Distilled/purified water c. Hydroxypropylcellulose (as Vegetable Cellulose) d. Glycerin USP/FCC grade e. Limonene (as fragrance) f. Aloe Vera extract Hand Sanitizer Label:", "50565-1": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Antiseptic, Hand Sanitizer", "Stop use": "Stop use and ask doctor if irritation and redness develop.", "Warnings": "For external use only. Flammable, keep away from flames.", "Questions": "Questions? Call 1-385-244-0470 Monday through Friday 8:30 AM to 5:00 PM MST.", "Directions": "• Rub hands thoroughly with product and allow to dry. • For children under 6, use only under adult supervision.", "Other information": "• Store below 110ºF (43ºC). • May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Isopropyl alcohol 70%", "Inactive ingredients": "Inactive ingredients Distilled Water, Structured Silver, Vegetable Cellulose, Glycerin, Aloe Vera, Fragrance.", "When using this product": "When using this product keep out of eyes. In case of contact, flush eyes with water.", "Package Label - Principal Display Panel": "2 FL OZ (59.15 mL) NDC: 75270-001-02"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:24.633308 · Updated: 2026-03-14T22:56:32.782909