hand sanitizer

SPL v3

SPL

SPL Set ID a4550315-1de4-7a60-e053-2a95a90a21bd

Route

topical

Published

Effective Date 2020-06-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (0.1 mL)

Inactive Ingredients

limonene, (+)- aloe vera leaf polysaccharides glycerin water hydroxypropyl cellulose, unspecified

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-28

Purpose

Antiseptic, Hand Sanitizer

Description

This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing: a. USP/FCC grade Ethyl alcohol 99% b. Distilled/purified water c. Hydroxypropylcellulose (as Vegetable Cellulose) d. Glycerin USP/FCC grade e. Limonene (as fragrance) f. Aloe Vera extract

Medication Information

Warnings

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

Uses

Decreases bacteria on skin.

Purpose

Antiseptic, Hand Sanitizer

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.

Inactive Ingredients

Inactive ingredients Distilled Water,

Structured Silver, Vegetable Cellulose,

Glycerin, Aloe Vera, Fragrance.

Description

Section 42229-5

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

a. USP/FCC grade Ethyl alcohol 99%

b. Distilled/purified water

c. Hydroxypropylcellulose (as Vegetable Cellulose)

d. Glycerin USP/FCC grade

e. Limonene (as fragrance)

f. Aloe Vera extract

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.

Questions

Questions? Call 1-385-244-0470 Monday

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

Active Ingredient(s)

Ethyl alcohol 70%

When Using This Product

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

8 Oz Packaging & Label Principal Display Panel

8 FL Oz (236 mL) - NDC: 75270-105-08

16 Oz Packaging & Label Principal Display Panel

16 FL Oz ( 473 mL) - NDC: 75270-105-16

32 Oz Packaging & Label Principal Display Panel

32 FL Oz ( 946 mL) - NDC: 75270-105-32

128 Oz Packaging & Label Principal Display Panel

1 Gallon (3.78 L) 128 FL Oz - NDC: 75270-105-28

Structured Label Content

Warnings

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

Uses

Decreases bacteria on skin.

Purpose

Antiseptic, Hand Sanitizer

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.

Inactive Ingredients (Inactive ingredients)

Inactive ingredients Distilled Water,

Structured Silver, Vegetable Cellulose,

Glycerin, Aloe Vera, Fragrance.

Section 42229-5 (42229-5)

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

a. USP/FCC grade Ethyl alcohol 99%

b. Distilled/purified water

c. Hydroxypropylcellulose (as Vegetable Cellulose)

d. Glycerin USP/FCC grade

e. Limonene (as fragrance)

f. Aloe Vera extract

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.

Stop Use (Stop use)

Stop use and ask doctor if irritation and redness develop.

Questions

Questions? Call 1-385-244-0470 Monday

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

Active Ingredient(s)

Ethyl alcohol 70%

When Using This Product (When using this product)

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

8 Oz Packaging & Label Principal Display Panel (8 oz Packaging & Label - Principal Display Panel)

8 FL Oz (236 mL) - NDC: 75270-105-08

16 Oz Packaging & Label Principal Display Panel (16 oz Packaging & Label - Principal Display Panel)

16 FL Oz ( 473 mL) - NDC: 75270-105-16

32 Oz Packaging & Label Principal Display Panel (32 oz Packaging & Label - Principal Display Panel)

32 FL Oz ( 946 mL) - NDC: 75270-105-32

128 Oz Packaging & Label Principal Display Panel (128 oz Packaging & Label - Principal Display Panel)

1 Gallon (3.78 L) 128 FL Oz - NDC: 75270-105-28

Advanced Ingredient Data

[{"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF POLYSACCHARIDES", "unii": "W21O437517", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "28.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

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 Ethyl alcohol 99% b. Distilled/purified water c. Hydroxypropylcellulose (as Vegetable Cellulose) d. Glycerin USP/FCC grade e. Limonene (as fragrance) f. Aloe Vera extract", "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)": "Ethyl 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.", "8 oz Packaging & Label - Principal Display Panel": "8 FL Oz (236 mL) - NDC: 75270-105-08", "16 oz Packaging & Label - Principal Display Panel": "16 FL Oz ( 473 mL) - NDC: 75270-105-16", "32 oz Packaging & Label - Principal Display Panel": "32 FL Oz ( 946 mL) - NDC: 75270-105-32", "128 oz Packaging & Label - Principal Display Panel": "1 Gallon (3.78 L) 128 FL Oz - NDC: 75270-105-28"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:31.417336 · Updated: 2026-03-14T22:58:05.187766