Emilia body & spa sanitizing hand cream

Emilia body and spa sanitizing hand cream by

Drug Labeling and Warnings

Emilia body and spa sanitizing hand cream by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EMILIA BODY AND SPA SANITIZING HAND CREAM- alcohol gel 
Emilia Cosmetics Ltd

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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Emilia body & spa sanitizing hand cream

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• instant hand antiseptic to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only

Flammable, keep away from open fire or flame.

When using this product

if contact with eyes occurs, rinse promptly thoroughly with water.

Stop use and ask a doctor if

significant irritation or sensitization develops.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• apply to clean, dry hands
• apply sufficient amount to thoroughly wet all surfaces of hands and fingers
• rub onto hands until dry
• supervise children in the use of this product.

Other information

store at 20-25C° (68-77°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C 10-14 isoparaffin, ethylhexylglycerin, fragrance, glycerin, hydrogenated polyisobutene, laureth-7, PEG-40 hydrogenated caster oil, polyacrylamide, tocopheryl acetate (Vitamine E), water.

Package Labeling:

EMILIA BODY AND SPA SANITIZING HAND CREAM 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-7 (UNII: Z95S6G8201)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-502-01	75 mL in 1 TUBE; Type 0: Not a Combination Product	07/10/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/10/2020	12/31/2022

Labeler - Emilia Cosmetics Ltd (600076624)

Revised: 6/2023

Document Id: fe6a1e6d-f20f-2479-e053-6294a90ad1b7

34390-5

Set id: aa546837-7756-d318-e053-2995a90a0690

Version: 2

Effective Time: 20230618