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 they comply 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 use in the eyes. Stop use and ask a doctor if irritation and redness develops 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. 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
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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.
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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
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