PURE O2 PACK-SOLID- sodium chlorite powder

PURE O2 Pack-Solid by

Drug Labeling and Warnings

PURE O2 Pack-Solid by is a Otc medication manufactured, distributed, or labeled by Pure O2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium chlorite

INACTIVE INGREDIENT

citric acid, sodium bisulfate

PURPOSE

anti bacteria, virus, odors

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

please see the label attached

WARNINGS

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE O2 PACK-SOLID 
sodium chlorite powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75124-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6)	SODIUM CHLORITE	23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BISULFATE (UNII: BU8V88OWIQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75124-0002-1	4 g in 1 POUCH; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2020

Labeler - Pure O2 (695881145)

Registrant - Pure O2 (695881145)

Establishment
Name	Address	ID/FEI	Business Operations
Pure O2		695881145	manufacture(75124-0002)