BioSilk Hand Sanitizer by Hirsch Gift, Inc

BioSilk Hand Sanitizer by

Drug Labeling and Warnings

BioSilk Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hirsch Gift, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOSILK HAND SANITIZER- biosilk hand sanitizer gel 
Hirsch Gift, 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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Dosage & Administration

Active ingredient Purpose
Ethyl Alcohol 77% v/v Antimicrobial

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

INACTIVE INGREDIENTS

Inactive ingredients
Aloe Barbadensis Leaf
Extract*, Aqua/Water/Eau,
Glycerin, Propanediol,
Acrylates/C10-30 Alkyl
Acrylate Crosspolymer,
Aminomethyl Propanol,
Fragrance (Parfum), Citral,
Limonene, Linalool
ID: 80-CHIOGAVHS
*organically grown aloe vera,
certification pending

ACTIVE INGREDIENTS

Active ingredient Purpose
Ethyl Alcohol 77% v/v Antimicrobial

ROUTE, METHOS AND FREQUENCY OF ADMINISTRATION

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

Directions
wet hands
thoroughly with
product and allow
to dry without
wiping
for children
under 6, use only
under adult
supervision

WARNINGS AND PRECAUTIONS

Warnings
Flammable, keep away from fire and flames.
For external use only.
When using this product
do not get into eyes
if contact occurs, rinse eyes
thoroughly with water
Stop use and ask a doctor if:
irritation and redness
develop
Keep out of reach of
children. If swallowed,
get medical help or
contact a Poison
Control Center right
away

STORAGE AND HANDLING

Other information
Do not store at
temperatures above
105°F

INDICATIONS & USAGE

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

Directions
wet hands
thoroughly with
product and allow
to dry without
wiping
for children
under 6, use only
under adult
supervision

WARNINGS

Warnings
Flammable, keep away from fire and flames.
For external use only.
When using this product
do not get into eyes
if contact occurs, rinse eyes
thoroughly with water
Stop use and ask a doctor if:
irritation and redness
develop
Keep out of reach of
children. If swallowed,
get medical help or
contact a Poison
Control Center right
away

OTC - KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

PRINCIPAL DISPLAY PANEL

Moisturizing Hand Sanitizer'

With Soothing Aloe Vera

KILLS 99.99% OF GERMS

92% Natural

MADE IN THE USA

12 FL OZ (355 mL)

BIOSILK HAND SANITIZER 
biosilk hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79515-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRAL (UNII: T7EU0O9VPP)	0.0275 g  in 100 g
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)	0.095 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	28.5 g  in 100 g
LINALOOL, (+)- (UNII: F4VNO44C09)	0.00475 g  in 100 g
WATER (UNII: 059QF0KO0R)	6.255 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T)	2 g  in 100 g
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.0715 g  in 100 g
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.14625 g  in 100 g
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)	0.4 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79515-000-12	355 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
2	NDC: 79515-000-25	739 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2020
3	NDC: 79515-000-99	3785 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020	11/04/2022

Labeler - Hirsch Gift, Inc (028109960)

Establishment
Name	Address	ID/FEI	Business Operations
Hirsch Gift, Inc		028109960	manufacture(79515-000)

Revised: 11/2022

Document Id: eca747a3-4d72-dd39-e053-2995a90a9451

34390-5

Set id: aa7cff06-d4b5-7de2-e053-2995a90a230c

Version: 2

Effective Time: 20221104