Prime by Sterling Perfumes Industries LLC Prime Hand Sanitizer

Prime by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRIME- isopropyl alcohol gel 
Sterling Perfumes Industries LLC

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Prime Hand Sanitizer

Active Ingredients

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

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 productkeep out of eyes, ears and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

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

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

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.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Other Information (if applicable)

• Store between 15-30 0C (59-86 0F), Avoid freezing and excessive heat above 40 0C (104 0F)

Inactive  ingredients

Aqua, Glycerin,Propylene Glycol, Isopropyl Myristate, Aminomethyl Propanol, Carbomer, Fragrance,Tocopheryl Acetate, Aloe barbadensis Leaf Extract.

100mL

500mL

PRIME 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77716-011
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77716-011-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
2	NDC: 77716-011-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
3	NDC: 77716-011-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/02/2020	12/30/2024

Labeler - Sterling Perfumes Industries LLC (561432456)

Revised: 1/2025

Document Id: 2c4182f0-4325-e0e2-e063-6394a90ab923

34390-5

Set id: c7c2feef-5b80-4b8d-9e86-0d2e21cd636c

Version: 3

Effective Time: 20250121