Natural Concepts Hand Sanitizer by Apollo Health and Beauty Care Inc. Drug Facts

Drug Details [pdf]

NATURAL CONCEPTS HAND SANITIZER- ethyl alcohol gel
Apollo Health and Beauty Care Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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 thoroughly with water. Do not inhale.

Do not use

on children less than 2 months 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 (Aqua), 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

image of the label

NATURAL CONCEPTS HAND SANITIZER
ethyl alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63148-516-11	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2020	12/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/23/2020	12/31/2024

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-516)

Revised: 2/2025

Document Id: 2d180956-5f20-0491-e063-6394a90abdbf

Set id: 9f7abd46-dfa1-4893-a248-afced94686db

Version: 2

Effective Time: 20250201