SPL v1
SPL
SPL Set ID a944e4fa-d519-6f65-e053-2a95a90a98e2
Route
TOPICAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Trolamine Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-29

Description

Active ingredients Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings

for external use only: hands

Flammable. Keep away from fire or flame

Indications and Usage

Uses hand sanitizer to help reduce bacteria on the skin . For occassional and personal domestic use

Dosage and Administration

Directions. Place enough product in your palm to thoroughly spread on both hands and rub into skin until dry.

Description

Active ingredients Ethyl Alcohol 62%

Section 44425-7

Other information. do not store above 105°F, may discolor some fabics. harmful to wood finished and plastics

Section 50565-1

Keep out of reach of children. children under 6, use only under adult supervision, Not recommended for infants.

For external use only. Do not drink.

If swallowed, seek professional assistance or contact a poison control center.

Section 50566-9

Stop use and consult a doctor if . irritation or redness develops. condition persists for more than 72 hours

Section 50567-7

when using this product, avoid contact with eyes, in case of contact, rinse eyes thoroughly with water, avoid contact with broken skin .

Section 51727-6

Inactive ingredients acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, water , triethanolamine,Fragrance. FD&C Blue No.1, FD&C Yellow No.5

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

Uses hand sanitizer to help reduce bacteria on the skin . For occassional and personal domestic use

Dosage and Administration (34068-7)

Directions. Place enough product in your palm to thoroughly spread on both hands and rub into skin until dry.

Warnings and Precautions (34071-1)

Warnings

for external use only: hands

Flammable. Keep away from fire or flame

Section 44425-7 (44425-7)

Other information. do not store above 105°F, may discolor some fabics. harmful to wood finished and plastics

Section 50565-1 (50565-1)

Keep out of reach of children. children under 6, use only under adult supervision, Not recommended for infants.

For external use only. Do not drink.

If swallowed, seek professional assistance or contact a poison control center.

Section 50566-9 (50566-9)

Stop use and consult a doctor if . irritation or redness develops. condition persists for more than 72 hours

Section 50567-7 (50567-7)

when using this product, avoid contact with eyes, in case of contact, rinse eyes thoroughly with water, avoid contact with broken skin .

Section 51727-6 (51727-6)

Inactive ingredients acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, water , triethanolamine,Fragrance. FD&C Blue No.1, FD&C Yellow No.5

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

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