SPL v1
SPL
SPL Set ID c39c1e29-39bb-0282-e053-2a95a90a68d5
Route
TOPICAL
Published
Effective Date 2021-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Alpha-tocopherol Aloe Benzalkonium Chloride Polysorbate 20 Water Glycerin Decyl Glucoside Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-31

Description

Ethyl alcohol 75%


Medication Information

Warnings and Precautions

Flammable, keep away from fire/flame

For external use only

Description

Ethyl alcohol 75%

Uses

hand wipes to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if. irritation and redness develop

condition persists for more than 72 hours

Section 50567-7

When using this product . do not get into eyes. ln case of contact,rinse eyes thoroughly with water

Section 50570-1

in children less than 12 months of age

on open skin wounds

as a baby wipe

Section 51727-6

Alkly dimethyl benzyl ammonium chloride

Aloe extract

Alpha tocopherol

Decyl glucoside

Glycerin

Phenoxyethanol

Polysorbate 20

water

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Ethyl alcohol 75%

Directions

open pouch by peeling back seal

wet hands thoroughly with product andallow to dry without wiping

reseal pouch after each use to preservemoisture

supervise children under 6 years of agewhen using this product to avoid swallowing

Other Information

store below 110°F(43°C)


Structured Label Content

Uses

hand wipes to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Warnings and Precautions (34071-1)

Flammable, keep away from fire/flame

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if. irritation and redness develop

condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product . do not get into eyes. ln case of contact,rinse eyes thoroughly with water

Section 50570-1 (50570-1)

in children less than 12 months of age

on open skin wounds

as a baby wipe

Section 51727-6 (51727-6)

Alkly dimethyl benzyl ammonium chloride

Aloe extract

Alpha tocopherol

Decyl glucoside

Glycerin

Phenoxyethanol

Polysorbate 20

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethyl alcohol 75%

Directions

open pouch by peeling back seal

wet hands thoroughly with product andallow to dry without wiping

reseal pouch after each use to preservemoisture

supervise children under 6 years of agewhen using this product to avoid swallowing

Other Information (Other information)

store below 110°F(43°C)


Advanced Ingredient Data


Raw Label Data

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