HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Doctor Fashion SAPI de CV, Absara Cosmetics SAPI de CV, TECNOGLOBAL PH7, Biu Lab S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin when water, soap & towel are not available – Recommended for repeated use.

Warnings

For external use only.

Flammable — Keep away from fire or flame.

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.

Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.

Keep out of reach of children.

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

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

• Do not store above 105 °F (40 °C).
• May discolor certain wood surfaces.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice.

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

HAND
SANITIZER

CONTAINS
70%
ETHYL
ALCOHOL

TOPICAL
SOLUTION

WITH
ALOE VERA

6.7 Fl. Oz. (200 ml)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75625-001
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
trolamine (UNII: 9O3K93S3TK)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
aloe vera leaf (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75625-001-01	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2020
2	NDC: 75625-001-02	415 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	02/05/2020

Labeler - Doctor Fashion SAPI de CV (951576481)

Establishment
Name	Address	ID/FEI	Business Operations
Absara Cosmetics SAPI de CV		816161236	MANUFACTURE(75625-001)

Establishment
Name	Address	ID/FEI	Business Operations
TECNOGLOBAL PH7		813006665	MANUFACTURE(75625-001)