FDA.reportPublic FDA data

Chamosyn

Manufacturer
Links Medical Products
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:31:23

Label at a glance#

ProductChamosyn Paraben Free
Active ingredientMENTHOL, ZINC OXIDE
Label structure12 sections

Indications and uses

Helps relieve the local discomfort, burning, and itching of the perianal area associated with anorectal disorders and inflamed hemorrhoidal tissues. Aids in protecting irritated anorectal areas. Dries the oozing and weeping of poison ivy oak sumac

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with clean tissue or a clean soft cloth before application of this product. Children under 12 years of age: consult a doctor. Apply externally to the affected area as needed up to 6 times daily or after each incontinence episode or diaper change.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Menthol 0.45% or 0.1%
  • Zinc oxide 20%

Purpose

OTC - PURPOSE SECTION

  • Anorectal analgesic/Anti-itch
  • Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve the local discomfort, burning, and itching of the perianal area associated with anorectal disorders and inflamed hemorrhoidal tissues.
  • Aids in protecting irritated anorectal areas.
  • Dries the oozing and weeping of poison
    • ivy
    • oak
    • sumac

Warnings

WARNINGS SECTION

For external use only.

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms do not improve within 7 days or clear up and occur again within a few days.

Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any medical device or applicator. Certain persons can develop allergic reactions to this product. If symptoms do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with clean tissue or a clean soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.
  • Apply externally to the affected area as needed up to 6 times daily or after each incontinence episode or diaper change.

Other information

OTHER SAFETY INFORMATION

Protect from freezing, avoid excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Chamosyn

Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water

Chamosyn - Paraben Free

Active aloe gel, Calamine, Caprylyl glycol, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Ethylhexylglycerin, Glycerin, Lanolin, Light mineral oil, Manuka honey, Microcrystalline wax, Petrolatum, Phenoxyethanol, Sodium borate, Sorbitan oleate, Tocopherol, Water

Questions?

OTC - QUESTIONS SECTION

(888) 425-1149

Chamosyn Ointment (0.45% Menthol)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label

001_Tube001_Tube

Packet Labels

001_Packets001_Packets

001_Packet Box001_Packet Box

Chamosyn Ointment (0.45% Menthol) - Paraben Free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label

51028-003-01 Tube Label51028-003-01 Tube Label

Packet Labels

51028-003-00 Packet Label51028-003-00 Packet Label

51028-003-00 Packet Box Label51028-003-00 Packet Box Label

Chamosyn Ointment (0.1% Menthol)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label

002_Chamosyn002_Chamosyn

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2730301Chamosyn 0.45 % / 20 % Topical OintmentPSN8
1998442menthol 0.1 % / zinc oxide 20 % Topical OintmentPSN8
884804menthol 0.45 % / zinc oxide 20 % Topical OintmentPSN8
2730301menthol 0.0045 MG/MG / zinc oxide 0.2 MG/MG Topical Ointment [Chamosyn]SBD8
1998442menthol 0.001 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCD8
884804menthol 0.0045 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCD8
2730301Chamosyn (menthol 0.45 % / zinc oxide 20 % ) Topical OintmentSY8
1998442Menthol 0.001 MG/MG / ZNO 0.2 MG/MG Topical OintmentSY8
884804Menthol 0.0045 MG/MG / ZNO 0.2 MG/MG Topical OintmentSY8
2730301menthol 0.0045 MG/MG / ZNO 0.2 MG/MG Topical Ointment [Chamosyn]SY8
1998442menthol 0.1 % / zinc oxide 20 % Topical OintmentSY8
884804menthol 0.45 % / zinc oxide 20 % Topical OintmentSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51028-002-012023-10-16C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-002023-10-16C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-012023-10-16C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-002-012021-07-23C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-002021-07-23C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-012021-07-23C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51028-001-00Chamosyn5 g in 1 PACKETOINTMENT58
51028-001-00Chamosyn144 in 1 BOXOINTMENT1448
51028-001-01Chamosyn113 g in 1 TUBEOINTMENT1138
51028-002-01Chamosyn113 g in 1 TUBEOINTMENT1138
51028-003-00ChamosynParaben Free5 g in 1 PACKETOINTMENT58
51028-003-00ChamosynParaben Free144 in 1 BOXOINTMENT1448
51028-003-01ChamosynParaben Free113 g in 1 TUBEOINTMENT1138

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51028-00351028-003-00, 51028-003-01
51028-00151028-001-00, 51028-001-01
51028-00251028-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
FERRIC OXIDE RED1K09F3G675IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHAMOMILEFGL3685T2XIACT
COD LIVER OILBBL281NWFGIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
HONEYY9H1V576FHIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BORATE91MBZ8H3QOIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
FERRIC OXIDE RED1K09F3G675IACT
CHAMOMILEFGL3685T2XIACT
COD LIVER OILBBL281NWFGIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
HONEYY9H1V576FHIACT
METHYLPARABENA2I8C7HI9TIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BORATE91MBZ8H3QOIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIB
SODIUM BORATE91MBZ8H3QOIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
ndc (package): 51028-001-01
ndc (package): 51028-003-01
ndc (package): 51028-002-01
ndc (package): 51028-001-00
ndc (package): 51028-003-00
ndc (product): 51028-001
ndc (product): 51028-002
ndc (product): 51028-003
ndc11 (package): 51028000100
ndc11 (package): 51028000301
ndc11 (package): 51028000101
ndc11 (package): 51028000201
ndc11 (package): 51028000300
spl id: 34a97f44-835c-ebb7-e063-6294a90a5b67
spl set id: f9dfb2d7-4684-4525-994e-1e0ff90413d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.