INSTANT UNSCENTED HAND SANITIZER WITH ALOE VERA ADVANCED- alcohol liquid

Instant Unscented Hand Sanitizer with aloe vera Advanced by

Drug Labeling and Warnings

Instant Unscented Hand Sanitizer with aloe vera Advanced by is a Otc medication manufactured, distributed, or labeled by Earths Amenities, DDI Multinacional, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) :

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerin
3. Aloe Vera Extract
4. Water
5. Caprylyl Glycol
6. Decylene Glycol
7. Benzoic Acid
8. Carbomer
9. Triethanolamine

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Uses

Antiseptic

Warnings

For external use only. Flammable. Keep away from fire or flame

WHEN USING

When using this product do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink

STOP USE

Stop use and ask a doctor if skin irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Other information

Store below 73.4F (23C)

Inactive ingredients

Water, aloe barbadensis (aloe vera extract), triethanolamine, glycerin, caprylyl glycol, decylene glycol, benzoic acid, carbomer

INDICATIONS & USAGE

To help reduce bacteria on the skin

Package Label - Principal Display Panel

60 mL NDC: 74949-002-60

250 mL NDC: 74949-002-25

495 mL NDC: 74949-002-49

20000 mL NDC: 74949-002-20

INGREDIENTS AND APPEARANCE

INSTANT UNSCENTED HAND SANITIZER WITH ALOE VERA ADVANCED 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74949-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	0.9 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL  in 100 mL
ALOE VERA FLOWER (UNII: 575DY8C1ER)	5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	25 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.5 mL  in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.1 mL  in 100 mL
DECYLENE GLYCOL (UNII: S57M60MI88)	0.1 mL  in 100 mL
BENZOIC ACID (UNII: 8SKN0B0MIM)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74949-002-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020
2	NDC: 74949-002-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020
3	NDC: 74949-002-49	495 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020
4	NDC: 74949-002-20	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020

Labeler - Earths Amenities (117473288)

Establishment
Name	Address	ID/FEI	Business Operations
Earths Amenities		117473288	label(74949-002)

Establishment
Name	Address	ID/FEI	Business Operations
DDI Multinacional, S.A. de C.V.		812776741	manufacture(74949-002)