E D ALCOHOL WIPE 1: Package Insert and Label Information

E D ALCOHOL WIPE 1- alcohol cloth
ENSOBRETADOS Y DERIVADOS S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 72%

PURPOSE

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS

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 eyes 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.

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

DIRECTIONS

■ Wet hands thoroughly. Allow to dry without wiping.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Water (Aqua), Isopropyl Alcohol, Glycerin, Fragrance.

QUESTIONS OR COMMENTS?

1-855-349-7735 or visit www.eydmx.com

E&D ALCOHOL WIPE 1 (NDC 78885-011-00)

E D ALCOHOL WIPE 1 ethyl alcohol cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78885-011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 72 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER ISOPROPYL ALCOHOL FRAGRANCE LAVENDER & CHIA F-153480 GLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78885-011-00 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/15/2020

Labeler — ENSOBRETADOS Y DERIVADOS S.A. DE C.V. (813382660)

Registrant — ENSOBRETADOS Y DERIVADOS S.A. DE C.V. (813382660)

Establishment
Name	Address	ID/FEI	Operations
COMPLETE SANITIZER LLC		117554312	pack (78885-011)

Establishment
Name	Address	ID/FEI	Operations
ENSOBRETADOS Y DERIVADOS S.A. DE C.V.		813382660	manufacture (78885-011)

Revised: 07/2020 ENSOBRETADOS Y DERIVADOS S.A. DE C.V.