MedPath

Clear Anti-Itch

Care One 218.002/218AF Clear Anti-Itch Lotion

Approved
Approval ID

a80b8fee-2dd9-4640-a4f8-4cf940df8563

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Retail Business Services, LLC

DUNS: 967989935

Products 1

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

Pramoxine HCl, Zinc acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72476-218
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pramoxine HCl, Zinc acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (13)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
POLYSORBATE 40Inactive
Code: STI11B5A2X
Classification: IACT
ROSEMARY OILInactive
Code: 8LGU7VM393
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PRAMOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 88AYB867L5
Classification: ACTIB
ZINC ACETATEActive
Quantity: 1 mg in 1 mL
Code: FM5526K07A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

Principal display panel

CAREONE ®

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC/SKIN PROTECTANT

Drying Action

Plus Itch Relief

PRAMOXINE HCl 1%

ZINC ACETATE 0.1%

Compare to the active ingredents of Caladryl ®Clear ®Lotion*

NET 6 FL OZ (177 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/7/2025

Uses

  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
  • dries the oozing and weeping of poison: -ivy -oak -sumac

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 7/7/2025

ADVERSE REACTION

DISTRIBUTED BY

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

1-833-992-3872

Quality guaranteed or your money back.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/7/2025

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl ®Clear ®Lotion.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/7/2025

Active ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/7/2025

Purpose

External analgesic

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 7/7/2025

Warnings

For external use only

OTC - WHEN USING SECTION

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

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/7/2025

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/7/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

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

Directions

  • shake well
  • before applying wash affected area of skin

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years - ask a doctor

STORAGE AND HANDLING SECTION

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

Other information

store at room temperature (59°-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/7/2025

Inactive ingredients

alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

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Clear Anti-Itch - FDA Drug Approval Details