SPL v1
SPL
SPL Set ID ad524f9c-cf6e-bc72-e053-2a95a90a2653
Route
TOPICAL
Published
Effective Date 2020-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
D&c Yellow No. 10 Isopropyl Myristate Rosemary Oil Fd&c Blue No. 1 Polyoxyl 40 Hydrogenated Castor Oil Carmoisine Water Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-20
Description

Ethyl Alcohol 70%

Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or source of ignition.

Indications and Usage

Hand sanitizer to help reduce bacteria on the skin it could cause disease

Dosage and Administration

Wet hand thoroughly with spray and rub hand together briskly until dry. Children under the age of 6 should be supervised while using this product. Not recommended for infants.

Description

Ethyl Alcohol 70%

Section 44425-7

Store at room temperature 66 oF to 77 oF ( 20 oC to 25 oC)

Section 50565-1

If swallowed, get medical attention or contact poison control center immediately

Section 51727-6

Purified water, Isopropyl myristate, Fragrance, Yellow ( C.I. 47005), Red (C.I. 14720), Blue ( C.I. 42090)

Section 51945-4

59ml NDC:79633-305-59

Section 55105-1

Antiseptic

Section 55106-9

Ethyl Alcohol 70%

Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria on the skin it could cause disease

Dosage and Administration (34068-7)

Wet hand thoroughly with spray and rub hand together briskly until dry. Children under the age of 6 should be supervised while using this product. Not recommended for infants.

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or source of ignition.

Section 44425-7 (44425-7)

Store at room temperature 66 oF to 77 oF ( 20 oC to 25 oC)

Section 50565-1 (50565-1)

If swallowed, get medical attention or contact poison control center immediately

Section 51727-6 (51727-6)

Purified water, Isopropyl myristate, Fragrance, Yellow ( C.I. 47005), Red (C.I. 14720), Blue ( C.I. 42090)

Section 51945-4 (51945-4)

59ml NDC:79633-305-59

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethyl Alcohol 70%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:31.494153 · Updated: 2026-03-14T22:58:06.962272