PRIMAL ELEMENTS MOISTURIZING HAND SANITIZER MIST - ALOHA BREEZE- alcohol spray

Primal Elements Moisturizing Hand Sanitizer mist - Aloha Breeze by

Drug Labeling and Warnings

Primal Elements Moisturizing Hand Sanitizer mist - Aloha Breeze by is a Otc medication manufactured, distributed, or labeled by ZheJiang Eshine Cosmetic Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

 Antiseptic

Use

• To decrease bacteria on the skin that could cause disease.
• Recommended for repeaed use.

Warnings

For external use only: hands

Flammable.Keep away from heat and flame.

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

Stop use and ask a doctor if

skin irritation develops.

Other Information

• Do not store above 105℉.
• May discolor some fabrics.
• Harmful to wood finisheds and plastics.

Keep out of reach of children.

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

Directions

• Spray directly on hands and rub in thoroughly.
• For children under 6, use only under adult supervision.
• Not recommended for infants.

Inactive ingredients

Water, Glycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Citric Acid, Sodium Benzoate, Potassium Sorbate, Red 40 (CI 16035)

SPL UNCLASSIFIED SECTION

Call 800-434-8277

Packaging

INGREDIENTS AND APPEARANCE

PRIMAL ELEMENTS MOISTURIZING HAND SANITIZER MIST - ALOHA BREEZE 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75262-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75262-011-01	45 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	08/21/2024

Labeler - ZheJiang Eshine Cosmetic Co Ltd (542987939)

Establishment
Name	Address	ID/FEI	Business Operations
ZheJiang Eshine Cosmetic Co Ltd		542987939	manufacture(75262-011)