Pristine by Transformaciones Del Caribe, Sociedad Anonima PRISTINE- alcohol gel

Pristine by

Drug Labeling and Warnings

Pristine by is a Otc medication manufactured, distributed, or labeled by Transformaciones Del Caribe, Sociedad Anonima. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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.

STOP USE

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

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

Inactive ingredients

Water, polyacrylic acid (Carbomer), triethanolamine (Trolamine), propylene glycol

Package Label - Principal Display Panel

3780 mL NDC: 78167-002-01

INGREDIENTS AND APPEARANCE

PRISTINE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78167-002
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
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.4 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78167-002-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/23/2020

Labeler - Transformaciones Del Caribe, Sociedad Anonima (817531659)

Registrant - Transformaciones Del Caribe, Sociedad Anonima (817531659)

Establishment
Name	Address	ID/FEI	Business Operations
Transformaciones Del Caribe, Sociedad Anonima		817531659	manufacture(78167-002)