Clear Anti-itch Lotion
FDA Label NDC 72476-218

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc for the product Clear Anti-itch (NDC 72476-218). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Uses

  • for the temporary relief of pain and itching associated with monor sking irritations and rashed due to poison ivy, poison oak or poison sumack
  • dries the oozing and weeping of poison: ivy - oak- sumac

Warnings

For external use only

When Using This Product

  • do not get into eyes

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

Keep Out Of Reach Of Children.

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

Directions

  • shake well
  • befor 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

Other Information

store at room temperature (59°-77° F)

Inactive Ingredients

alcohol, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hydroxypropyl methylcellulose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben,purified water, sodium citrate

Other

This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Clear Lotion*

DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
QUALITY GUARANTEED OR YOUR MONEY BACK

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*

6 FL OZ (177mL)

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Image Description (Mm3)

* Please review the disclaimer below.