HAND SANITIZER WITH ALOE VERA- alcohol gel

Hand Sanitizer with aloe vera by

Drug Labeling and Warnings

Hand Sanitizer with aloe vera by is a Otc medication manufactured, distributed, or labeled by Pharmco Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

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

Do not use

• in children less that 2 months of age
• on open wounds

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Discontinue use if irritation or redness develops.

If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children. If swallowed get medical help or call a poison control center immediately.

Directions

• Place enough product in your palm to thoroughly cover your hands.
• Rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other Information

• Store below 43°C (110°F)
• May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Hydroxide

SPL UNCLASSIFIED SECTION

Manufactured by:
Pharmco Laboratories, Inc.
3520 South St. Titusville, FL 32780

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label

pharmco
MANUFACTURER OF PREMIUM SKIN CARE PRODUCTS

HAND
SANITIZER
with aloe vera

2 fl oz. (59 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER WITH ALOE VERA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58400-010
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
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58400-010-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 58400-010-04	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
3	NDC: 58400-010-08	228 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
4	NDC: 58400-010-30	885 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
5	NDC: 58400-010-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
6	NDC: 58400-010-55	207000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - Pharmco Laboratories, Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories, Inc.		096270814	MANUFACTURE(58400-010) , LABEL(58400-010) , PACK(58400-010)