HAWAIIAN AIRLINE EC WITH COLGATE TOOTHBRUSH AND SUN- sodium monofluorophosphate, zinc oxide kit

Hawaiian Airline EC with Colgate Toothbrush and Sun by

Drug Labeling and Warnings

Hawaiian Airline EC with Colgate Toothbrush and Sun by is a Otc medication manufactured, distributed, or labeled by Luoding Quality Amenities Supply Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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)

Package Labling: (

42555-060-94)

Package Labling: (

70680-308-00)

INGREDIENTS AND APPEARANCE

HAWAIIAN AIRLINE EC WITH COLGATE TOOTHBRUSH AND SUN 
sodium monofluorophosphate, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72135-029

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72135-029-02	1 in 1 KIT	08/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	5 g
Part 2	1 PACKET	4 g

Part 1 of 2

COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 42555-060
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42555-060-94	5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2019

Part 2 of 2

RAW ELEMENTS ECO FORMULA SPF30 SAMPLE PACKS 
zinc oxide lotion

Product Information
Item Code (Source)	NDC: 70680-308
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	230 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WHITE WAX (UNII: 7G1J5DA97F)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70680-308-00	4 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2019

Labeler - Luoding Quality Amenities Supply Limited (528126807)