Primal Elements Isopropyl Rubbing Alcohol USP

Primal Elements Isopropyl Alcohol by

Drug Labeling and Warnings

Primal Elements Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil, Spa de Soleil, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRIMAL ELEMENTS ISOPROPYL ALCOHOL- isopropyl alcohol solution 
Spa de Soleil

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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Primal Elements Isopropyl Rubbing Alcohol USP

Drug Facts

Active Ingredient

Isopropyl Alcohol 70%

Purpose:

First Aid Antiseptic

Uses first aid to help prevent the risk of infection in: minor cuts, scrapes, burns.

Warnings For external use only

Flammable

• Keep away from fire or flame, heat, spark, electrical. Flash point 72°F.
• do not use with eletocautery procedures.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

When using this product

• do not get into eyes
• do not apply over large areas of the body
• do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if condition persists or gets worse

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

<Directions clean the affected area. apply 1 to 3 times daily.

Other information does not contain, nor is intended as a substitue for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally.

Inactive Ingredient purified water

Principal Display Panel

PRIMAL ELEMENTS ISOPROPYL ALCOHOL 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-2290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	305.9 mL  in 437 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-2290-1	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2020
2	NDC: 68062-2290-2	943 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020	01/08/2023

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil, Inc.		874682867	manufacture(68062-2290)

Revised: 1/2023

Document Id: f1c95a60-2b74-e875-e053-2a95a90ac9f4

34390-5

Set id: af88af65-c519-1f20-e053-2a95a90a195f

Version: 2

Effective Time: 20230108