INSTACLEAN HAND SANITIZER- alcohol gel

InstaClean by

Drug Labeling and Warnings

InstaClean by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

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. Children should be supervised by an adult when using this product.

Uses

• To decrease bacteria on the skin that potentially can cause disease
• Recommended for repeated use

Warnings

• Flammable, keep away from heat or flame.
• For external use only.

Safety Information

May discolor certain fabrics and surfaces.

Stop use

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

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Inactive ingedients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

InstaClean 18 oz Front

AmeriDerm

InstaClean™

Instant Hand Sanitizer

Reorder No: 245

Rev: 1.0

245-Front

InstaClean 18 oz Back

InstaClean™

Instant Hand Sanitizer

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses

• To decrease bacteria on the skin that potentially can cause disease
• Recommended for repeated use

Warnings

• Flammable, keep away from heat or flame.
• For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

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

Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Other Information

May discolor certain fabrics and surfaces.

Inactive Ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

AMD-80463

Manufactured for:

Shield Line LLC,

Hackensack, NJ 07601 USA

www.ameriderm.com                                                   Bar code

Rev: 1.0                245-Back                                              52410 80463

InstaClean 18 oz case

REORDER NO: ALL-245	AMD-80463	AmeriDerm
INSTACLEAN Wt:   532 ml (18 FL Oz) Qty:  12 Pouches		Rev, 1.0 245-CS

Manufactured for: Hackensack, NJ 07601 Made In USA                                               20-80463AD-02

Bar Code                                                                                                              16 PUMP BOTTLES

1 03 52410 80463 9                                                                                         PER CASE

                                                                                                                                UOM: CS

InstaClean 800 ml pouch

All-246-404          Rev. 1.0

AmeriDerm

• InstaClean™ Instant Hand Sanitizer:

  Drug Facts

  Active Ingredient Purpose

  Ethyl Alcohol 70% v/v …………….. Antiseptic

  Uses

  • To decrease bacteria on the skin that potentially can cause disease
  • Recommended for repeated use

  Warnings

  • Flammable, keep away from heat or flame.
  • For external use only.

  Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

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

  Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

  Directions

  • Apply sufficient amount of product to your palm to cover both hands.
  • Rub until dry.

  Other Information

  May discolor certain fabrics and surfaces.

  Inactive Ingredients

  Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Manufactured for Shield Line LLC

Hackensack, NJ 07601 USA

                                Bar Code

800 ml                  52410 80464

InstaClean 800 ml case

REORDER NO: ALL-246	AMD-80464	AmeriDerm
INSTACLEAN Wt:   800ml (27 FL Oz) Qty:  12 Pouches		Rev, 1.0 AMD-80464-CS

Manufactured for: Hackensack, NJ 07601 Made In USA                                               20-80464AD-02

Bar Code                                                                                                              12 POUCHES

1 03 52410 80464 6                                                                                              PER CASE

                                                                                                                                UOM: C5

InstaClean 4 oz front

AmeriDerm

InstaClean™

Instant Hand Sanitizer

Reorder No: 242                118 ml (4 fl oz)

242-Front                            Rev: 1.1

InstaClean 4 oz back

InstaClean™

Instant Hand Sanitizer

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses

• To decrease bacteria on the skin that potentially can cause disease
• Recommended for repeated use

Warnings

• Flammable, keep away from heat or flame.
• For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

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

Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Other Information

May discolor certain fabrics and surfaces.

Inactive Ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

AMD-80463

Manufactured for:

Shield Line LLC,

Hackensack, NJ 07601 USA

www.ameriderm.com                                                   Bar code

Rev: 1.0                242-Back                                              52410 80462

InstaClean 4 oz case

AmeriDerm
REORDER NO: ALL-242	AMD-80462
INSTACLEAN Wt:   4 FL OZ Qty:  24 Bottles

Manufactured for: Hackensack, NJ 07601 Made In USA              

• SIZE: 118 ml (4 FL OZ):

  24 Bottles Per Case

242-CS  Rev. 1.1                20-80462AD-01                                  UOM: CS

Bar Code                                                                                                             

1 03 52410 80462 2   

INGREDIENTS AND APPEARANCE

INSTACLEAN  HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-139
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
PERFLUOROALKYLETHYL ACRYLATES (C6-C14) (UNII: TKA54G588X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-139-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-139-02	2832 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 58575-139-03	800 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2018
4	NDC: 58575-139-04	9600 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018
5	NDC: 58575-139-05	532 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2018
6	NDC: 58575-139-06	6384 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2018

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-139)