RECESSA HAND SANITIZER- alcohol gel

Recessa Hand Sanitizer by

Drug Labeling and Warnings

Recessa Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Specialty Formulations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

to reduce disease causing bacteria
on the skin when soap and water not
available

Warnings

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

When using this product

■ Keep out of eyes,
ears, and mouth. In case of contact with
eyes, rinse eyes thoroughly with water.

Do not use:

■ on open skin wounds

■ in children less than 2 months of age

Stop use and ask a doctor if:

Skin irritation or rash develop

Keep out of reach of children. If swallowed,
seek medical help or contact Poison Control
Center right away

Directions:

Place enough product on hands
to cover all surfaces. Rub hands together
until dry. ■ for children under 6, use only
under adult supervision

Other Information:

■ Store between 15°- 30°C (59°- 86° F)
■ Avoid freezing and excessive heat
above 40°C (104°F

Inactive Ingredients:

Aloe Vera Gel,
Carbomer, Glycerin, Vitamin E, Purified
Water, Triethanolamine and Witch Hazel

Package Label - Principal Display Panel

Recessa

Hand Sanitizer

Gel

70% Alcohol

with Moisturizers

16oz (473 ml)

INGREDIENTS AND APPEARANCE

RECESSA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70420-001
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)
TROLAMINE (UNII: 9O3K93S3TK)
WITCH HAZEL (UNII: 101I4J0U34)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70420-001-19	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/28/2020
2	NDC: 70420-001-17	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/28/2020
3	NDC: 70420-001-18	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/28/2020

Labeler - Specialty Formulations (003989912)

Registrant - Specialty Formulations (003989912)

Establishment
Name	Address	ID/FEI	Business Operations
Specialty Formulations		003989912	manufacture(70420-001)