United Airlines Polaris Kit with Sanitizer Wipe

United Airlines Polaris Kit with Sanitizer Wipe by

Drug Labeling and Warnings

United Airlines Polaris Kit with Sanitizer Wipe by is a Otc medication manufactured, distributed, or labeled by Buzz Products (HK) Co. Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNITED AIRLINES POLARIS KIT WITH SANITIZER WIPE- alcohol, sodium monofluorophosphate 
Buzz Products (HK) Co. Limited

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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United Airlines Polaris Kit with Sanitizer Wipe

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Purpose

Antiseptic

Uses

  • To help reduce bacteria on the skin.

Warnings

  • For external use only.
  • Do not dispose of wipe in flush toilets.

Flammable

  • Keep away from fire or flame.

When using this product

  • avoid contact with eyes,
  • If contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

  • Apply to hands or surfaces.
  • No rinsing required.
  • Discard after use.

Other Information

  • Store below 110°F (43°C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

Aqua (Water), Glycerin, Polyquaternium-37, Melaleuca Alternifolia Leaf Oil.

Active ingredient

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

 adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
 children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 children under 2 years ask a dentist or physician

Inactive ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call to-free 1-800-468-6502

Package Labeling:70402-259-01

Kit3

Package Labeling:70402-256-01

Bottle

Package Labeling:42555-060-94

LabelLabel2Label3Label4

UNITED AIRLINES POLARIS KIT WITH SANITIZER WIPE 
alcohol, sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70402-259
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70402-259-011 in 1 KIT01/11/202112/31/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PATCH 5 mL
Part 21 TUBE 5 g
Part 1 of 2
UNITED AIRLINES SANITIZER WIPE 
alcohol cloth
Product Information
Item Code (Source)NDC: 70402-256
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70402-256-011 in 1 POUCH
15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/11/202112/31/2021
Part 2 of 2
COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Item Code (Source)NDC: 42555-060
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42555-060-945 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/11/202112/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/11/202112/31/2021
Labeler - Buzz Products (HK) Co. Limited (663516515)

Revised: 12/2021