SPL v2
SPL
SPL Set ID ada5c73e-8946-52e0-e053-2a95a90a1cc2
Route
TOPICAL
Published
Effective Date 2020-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Glycerin Allantoin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-25

Description

alcohol


Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Indications and Usage

When you wish to sanitize your hands, and after you wash your hands

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

keep out of reach of the children

Section 51727-6

glycerin, allantoin, water, butylene glycol, niacinamide, DL-panthenol, xylitol, glycine, aloe vera leafr, acorus calamus extract, panax ginseng extract, cortex mori extract, paeonia lactiflora root extract, swertia pseudochinensis extract, citrus unshiu peel extract, fragrance

Section 51945-4

Section 55105-1

hand sanitizer

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

When you wish to sanitize your hands, and after you wash your hands

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

glycerin, allantoin, water, butylene glycol, niacinamide, DL-panthenol, xylitol, glycine, aloe vera leafr, acorus calamus extract, panax ginseng extract, cortex mori extract, paeonia lactiflora root extract, swertia pseudochinensis extract, citrus unshiu peel extract, fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

hand sanitizer

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)