HAWAIIAN AIRLINE EC WITH COLGATE TOOTHBRUSH AND SUN- sodium monofluorophosphate, zinc oxide 
Luoding Quality Amenities Supply 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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Hawaiian Airline Kit (EC) with 5g Colgate + Toothbrush and Sun Cream

Drug Facts

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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask 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 toll-free 1-800-468-6502

Drug Facts

Active Ingredients

Zinc Oxide 23%

Purpose

Sunscreen

Uses:

Helps prevent sunburn

Warnings:

For external use only.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if skin rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating, Immediately after towel drying, at least every 2 hours. Children under 6 months: Ask a doctor

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Organic Coffee Bean), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary), Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol *Certified Organic

Other Information:

Protect this product from excessive heat and direct sun.

Package Labling: (72135-029-02)

KitKit2Kit3

Package Labling: (42555-060-94)

5g LabelDrug Facts Panel

Package Labling: (70680-308-00)

Label2Label3

HAWAIIAN AIRLINE EC WITH COLGATE TOOTHBRUSH AND SUN 
sodium monofluorophosphate, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72135-029
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72135-029-021 in 1 KIT08/01/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 5 g
Part 21 PACKET 4 g
Part 1 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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
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 finalpart35508/01/2019
Part 2 of 2
RAW ELEMENTS ECO FORMULA SPF30 SAMPLE PACKS 
zinc oxide lotion
Product Information
Item Code (Source)NDC:70680-308
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION230 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WHITE WAX (UNII: 7G1J5DA97F)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70680-308-004 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2019
Labeler - Luoding Quality Amenities Supply Limited (528126807)

Revised: 11/2021
 
Luoding Quality Amenities Supply Limited