SeneGence Hand Sanitizer 70% Alcohol by Cosmetic Specialty Labs, Inc. SeneGence Hand Sanitizer

SeneGence Hand Sanitizer 70% Alcohol by

Drug Labeling and Warnings

SeneGence Hand Sanitizer 70% Alcohol by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENEGENCE HAND SANITIZER 70% ALCOHOL- alcohol hand sanitizer gel 
Cosmetic Specialty Labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SeneGence Hand Sanitizer

Drug Facts

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable - Keep away from fire or flame.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts. These may be signs of a serious condition..

Keep out of reach of children

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

Directions

Use enough product in your palm to cover

hands and rub hands together briskly until dry.

Children under 6 years of age should be

supervised when using this product.

Other information

• Do not store above 110°F (43°C)
• May discolor fabrics or surfaces

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) Leaf Juice, Butylene Glycol,
Caprylyl Glycol, Carbomer, Matricaria (Chamomilla
Recutita) Flower Extract, Glycerin, Phenoxyethanol, Water,
Tocopheryl Acetate, Triethanolamine.

SENEGENCE HAND SANITIZER 70% ALCOHOL 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-958
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
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER 940 (UNII: 4Q93RCW27E)
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-958-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2020	12/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/13/2020	12/15/2021

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-958)

Revised: 12/2021

Document Id: d33800ec-d281-9108-e053-2a95a90a2755

34390-5

Set id: acc1fd4c-786a-f475-e053-2a95a90aba07

Version: 2

Effective Time: 20211215