OTC Medication Information: E D ALCOHOL WIPE 1

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
(click image for full-size original)

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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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