JETBLUE ANTISEPTIC HAND SANITIZER- alcohol Global-C Nederland B.V.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

JetBlue Antiseptic Hand Sanitizer Kit

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

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

Do not usein the eyes.

Stop use and ask a doctor if irritation and redness developscondition 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.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 77 °F (25 °C)

Inactive ingredients

alpha tocopheryl acetate, monopropylene glycol, peg-7 glyceryl cocoate, polyacrylic acid, triclosan,triethanolamine, water

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

or external use onlyFlammable, keep away from fire or flame.

Do not usein the eyes.

Stop use and ask a doctor ifirritation and redness developscondition 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.

Directions

wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 77 °F (25 °C)

Inactive ingredients

cellulose fiber, PEG -7 glyceryl cocoate, polyester fiber, water

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use onlyFlammable, keep away from fire or flame.

Do not usein the eyes.

Stop use and ask a doctor ifirritation and redness developscondition 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.

�Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 77 °F (25 °C)

Inactive ingredients

alpha tocopheryl acetate, monopropylene glycol, peg-7 glyceryl cocoate, polyacrylic acid, triclosan,triethanolamine, water

Package Labeling: Kit

Package Labeling: 1 Towel

Package Labeling: 3ML

JETBLUE ANTISEPTIC HAND SANITIZER alcohol kit

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:78 6 57-0 0 3

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:78 6 57-0 0 3-0 1 1 in 1 KIT 0 6 /30 /20 20

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 2 PATCH 6 mL

Pa rt 2 1 BAG 3 mL

Part 1 of 2

ANTISEPTIC TOWEL 65 ETHYL ALCOHOL alcohol cloth

Product InformationIte m Code (Source ) NDC:78 6 57-0 0 1

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 0 .6 5 mL in 1 mL

Inactive IngredientsIngredient Name Strength

PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)

WATER (UNII: 0 59 QF0 KO0 R)

Packaging

# Item Code Package Description Marketing StartDate

Marketing EndDate

1 NDC:78 6 57-0 0 1-0 1 2 in 1 POUCH

1 3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device /System(syringe , pa tch, e tc .)

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part333E 0 6 /30 /20 20

Part 2 of 2

ALCOHOL antiseptic hand sanitizer 65 ethyl gel

Product InformationIte m Code (Source ) NDC:78 6 57-0 0 2

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 0 .6 5 mL in 1 mL

Inactive IngredientsIngredient Name Strength

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)

Global-C Nederland B.V.

TRICLO SAN (UNII: 4NM50 39 Y5X)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:78 6 57-0 0 2-0 1 3 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part333E 0 6 /30 /20 20

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part333E 0 6 /30 /20 20

Labeler - Global-C Nederland B.V. (386762558)

Revised: 7/2020