MedPath

TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes

43116-045

Approved
Approval ID

3d53463d-8d8e-9030-e063-6294a90ab454

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 1, 2025

Manufacturers
FDA

Shenzhen Shierjie Biological Engineering Co., LTD

DUNS: 547610261

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43116-045
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 1, 2025
FDA Product Classification

INGREDIENTS (10)

PURSLANEInactive
Code: M6S840WXG5
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CHRYSANTHELLUM INDICUM TOPInactive
Code: STJ856D1Z0
Classification: IACT
HOUTTUYNIA CORDATA FLOWERING TOPInactive
Code: RH041UUZ22
Classification: IACT
OPUNTIA STREPTACANTHA STEMInactive
Code: 3TF9Z1U73O
Classification: IACT
SCUTELLARIA BAICALENSIS ROOTInactive
Code: 7J95K7ID2S
Classification: IACT
PAEONIA X SUFFRUTICOSA ROOTInactive
Code: 7M7E9A2C8J
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
LACTIC ACIDActive
Quantity: 1.5 U in 100 U
Code: 33X04XA5AT
Classification: ACTIB
POLYAMINOPROPYL BIGUANIDEActive
Quantity: 0.2 U in 100 U
Code: DT9D8Z79ET
Classification: ACTIB

TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43116-044
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (10)

PURSLANEInactive
Code: M6S840WXG5
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CHRYSANTHELLUM INDICUM TOPInactive
Code: STJ856D1Z0
Classification: IACT
HOUTTUYNIA CORDATA FLOWERING TOPInactive
Code: RH041UUZ22
Classification: IACT
OPUNTIA STREPTACANTHA STEMInactive
Code: 3TF9Z1U73O
Classification: IACT
SCUTELLARIA BAICALENSIS ROOTInactive
Code: 7J95K7ID2S
Classification: IACT
PAEONIA X SUFFRUTICOSA ROOTInactive
Code: 7M7E9A2C8J
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
LACTIC ACIDActive
Quantity: 1.5 U in 100 U
Code: 33X04XA5AT
Classification: ACTIB
POLYAMINOPROPYL BIGUANIDEActive
Quantity: 0.2 U in 100 U
Code: DT9D8Z79ET
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/27/2025

PRINCIPAL DISPLAY PANEL

10

50

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2025

Use

Daily intimate area cleansing, removal of menstrual blood and odors, and hygiene during travel, pregnancy,
postpartum, or before and after intimacy.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/27/2025

Active Ingredient

Lactic Acid 1.5%

Polyaminopropyl Biguanide 0.2%

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/27/2025

Other information

Store in a cool, dry place, away from light, in a sealed and
moisture-proof container.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/27/2025

Purpose

Antimicrobial

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/27/2025

Do not use

Do not take orally.
Avoid on wounds, eczema, or inflamed skin.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/27/2025

When Using

Do not take orally. Keep out of reach of children.
Consult doctor before use with medications. Discontinue if allergic.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/27/2025

Stop Use

Stop use if redness/swelling/itching occurS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/27/2025

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a Poison Control
Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/27/2025

Directions

Openthe package and genty wipe the exteral itimate
area from front to back. No rinsing required. Single-use
only.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/27/2025

Inactive ingredients

Glycerin, Portulaca Oleracea Extract, Chrysanthellum Indicum Extract, Houttuynia Cordata Extract, Opuntia
Streptacantha Stem Extract, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Bark Extract, Bifida
Ferment Filtrate, Butylene Glycol.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 8/27/2025

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TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes - FDA Drug Approval Details