Prime Collection by Premier Cosmetics / Sterling Perfumes Industries LLC

Prime Collection by

Drug Labeling and Warnings

Prime Collection by is a Otc medication manufactured, distributed, or labeled by Premier Cosmetics, Sterling Perfumes Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRIME COLLECTION- alcohol liquid 
Premier Cosmetics

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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Active Ingredient

Isopropyl alcohol 70% v/v.

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-300C (59-860F).
Avoid freezing and excessive heat above 400C (1040F).

Inactive ingredients

Aqua, Glycerin, Propylene Glycol, Isopropyl Myristate, Benzalkonium Chloride, Fragrance, Tocopheryl Acetate, Aloe barbadensis Leaf Extract.

Package Label - Principal Display Panel

Label 50 mL

Label 100 mL

PRIME COLLECTION 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78117-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78117-003-01	50 mL in 1 CAN; Type 0: Not a Combination Product	06/01/2020	06/12/2020
2	NDC: 78117-003-02	100 mL in 1 CAN; Type 0: Not a Combination Product	06/01/2020	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	06/12/2020

Labeler - Premier Cosmetics (557941540)

Establishment
Name	Address	ID/FEI	Business Operations
Sterling Perfumes Industries LLC		561432456	manufacture(78117-003)

Revised: 6/2020

Document Id: f7bd9466-ab0c-4ecd-bcf2-f4513c0ce794

34390-5

Set id: 423f9012-4485-4597-9829-081b69b4c18e

Version: 2

Effective Time: 20200611