Primal Elements Hydrogen Peroxide

Primal Elements Hydrogen Peroxide by

Drug Labeling and Warnings

Primal Elements Hydrogen Peroxide 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 HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid 
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 Hydrogen Peroxide

Active ingredient

Hydrogen peroxide 3%

Purpose

first aid antiseptic/oral debriding agent

Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes and burns
• aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use only.

Do not use

• in the eyes or apply over large areas of the body
• longer than one week

Ask a doctor before use if you have

• deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

• swelling, rash, or fever develops
• the condition persists or gets worse
• sore mouth symptoms do not improve in 7 days 
• irritation, pain or redness persists or worsens

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

For use as a first aid antiseptic:

• clean affected area
• if bandaged, let dry first
• apply small amount of product on affected area 1-3 times a day
• may be covered with a sterile bandage

For use as an oral debriding agent (oral rinse):

• adults and children 2 years of age and over:
• mix with an equal amount of water
• swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
• children under 12 years should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor

Other information

• Keep tightly closed and in a dark place at room temperature.
• Do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water

Princiapl Display Panel

PRIMAL ELEMENTS HYDROGEN PEROXIDE  3 PERCENT
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-2292
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	14.19 mL  in 473 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-2292-1	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2020
2	NDC: 68062-2292-2	946 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	part356	08/03/2020	01/08/2023

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil, Inc.		874682867	manufacture(68062-2292)

Revised: 1/2023

Document Id: f1c95a60-2b75-e875-e053-2a95a90ac9f4

34390-5

Set id: af88f422-bb21-c3fa-e053-2a95a90a2652

Version: 2

Effective Time: 20230108