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NDC 81745-0501-03 Champuregreen 0.005 mg/100mL Details

Champuregreen 0.005 mg/100mL

Champuregreen is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by PROSAFEBIO. The primary component is HYPOCHLOROUS ACID.

Product Information

NDC	81745-0501
Product ID	81745-501_eb81f9e8-008a-0a46-e053-2995a90a8847
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Champuregreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hypochlorous acid
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.005
Active Ingredient Units	mg/100mL
Substance Name	HYPOCHLOROUS ACID
Labeler Name	PROSAFEBIO
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 81745-0501-03 (81745050103)

Pricing Information	N/A
NDC Package Code	81745-501-03
Billing NDC	81745050103
Package	17 mL in 1 CONTAINER (81745-501-03)
Marketing Start Date	2021-09-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c1f41156-83f4-c6af-e053-2995a90a0897 Details

Active ingredient[s]

HOCL(Hypochlorous acid) 0.005%

Purpose

Antiseptic

Use[s]

Helps reduce disease-causing germs and viruses that may exist on objects and in spaces.

Warnings

For external use only

Do not use

Do not mix with water or other chemicals.
Do not spray directly on electric products or electronics.
Do not use the product for any other purpose than its intended purpose.

Keep out of reach of children

Keep out of reach of children.

Stop use

If swallowed, drink enough water. If abnormal symptoms occur, get medical help.
Keep out of eyes. In case of contact with eyes, flush thoroughly with clean water. If abnormal symptoms occur, consult a doctor.
Stop use if skin irritation or redness develops.

Directions

Spray from a certain distance on where disinfection is needed.
Use frequently when needed.
Let it to dry or wipe with a cloth.

Other information

Best before : 6 months after opening

Expiration date : indicated separately

Store at room temperature and avoid direct sunlight and high temperatures.

Inactive ingredient

Purified Water

Package Label

INGREDIENTS AND APPEARANCE

CHAMPUREGREEN

hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81745-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.005 mg in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81745-501-01	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/10/2021
2	NDC:81745-501-02	80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/10/2021
3	NDC:81745-501-03	17 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/16/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/10/2021

Labeler - PROSAFEBIO (695501710)

Registrant - PROSAFEBIO (695501710)

Name	Address	ID/FEI	Business Operations
Establishment
PROSAFEBIO		695501710	manufacture(81745-501)

Revised: 10/2022

Document Id: eb81f9e8-008a-0a46-e053-2995a90a8847

Set id: c1f41156-83f4-c6af-e053-2995a90a0897

Version: 7

Effective Time: 20221020