ADVANCED HAND SANITIZER FOAM WITH ALOE- alcohol solution
DEALMED MEDICAL SUPPLIES LLC

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.

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Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that can cause disease. recommended for repeat use

Warnings

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

Do not use

In children less than 2 months of age
On open skin wounds

Do not use in or near the eyes. in case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
Children under 6 years of age should be supervised when using this product.

Other information

Store below 110FC (43C).
May discolor certain fabrics or surfaces.

Inactive ingredients

Water, PEG-12 Dimethicone, Carprylyl Glycol, Aloe Vera, Glycerin, Fragrance

Package Label - Principal Display Panel

Foam Hand Sanitizer 473.2 mL NDC: 78257-916-01

ADVANCED HAND SANITIZER FOAM WITH ALOE
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78257-916
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78257-916-01	473.2 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - DEALMED MEDICAL SUPPLIES LLC (078864775)

Name	Address	ID/FEI	Business Operations
Establishment
PELICAN GROUP LLC, THE		078435913	manufacture(78257-916)