NATURAL CONCEPTS HAND SANITIZER- ethyl alcohol gel

Natural Concepts Hand Sanitizer by

Drug Labeling and Warnings

Natural Concepts Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care Inc., Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only

• flammable
• keep away from source of heat or fire

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Do not use

• on children less than 2 month of age
• on open skin wounds
• on broken or damaged skin
• if you are pregnant or breastfeeding

Stop use and ask a doctor if 

irritation or redness develops and lasts

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• Adults only
• For occasional and personal use
• Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information

• store at a temperature below 110°F (43°C)
• may discolor certain fabrics or surfaces

Inactive ingredients

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer

Questions or comments?

1-866-695-3030

Label copy

INGREDIENTS AND APPEARANCE

NATURAL CONCEPTS HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-516-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/11/2020

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		825646862	manufacture(63148-516)