INSTANT HAND SANITIZER WITH ALOE 66.5% ETHYL ALCOHOL- ethyl alcohol gel
Ems Acquisition Corp.

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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EMS (as PLD) - INSTANT HAND SANITIZER WITH ALOE (59228-501)

ACTIVE INGREDIENTS

Ethyl Alcohol 66.5%

PURPOSE

Antiseptic

USES

for handwashing to decrease bacteria on skin without soap and water
recommended for repeated use

WARNINGS

For external use only
Flammable. Keep away from fire or flame
Do not use in the eyes. If this happens, rinse thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

Keep out of reach of children.

If ingested get medical help or contact a Poison Control Center right away.

DIRECTIONS

wet hands and wrists thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

INACTIVE INGREDIENTS

purified water, aloe vera, triethonolamine, carbomer, D&C blue #1, D&C yellow #10, fragrance

01b LBL_EMS_Instant Hand Sanitizer

INSTANT HAND SANITIZER WITH ALOE 66.5% ETHYL ALCOHOL
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59228-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66.5 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59228-501-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/18/2022

Labeler - Ems Acquisition Corp. (048602791)

Registrant - Ems Acquisition Corp. (048602791)