Dermamine
FDA Label NDC 67234-023

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex Llc for the product Dermamine (NDC 67234-023). 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 other, otc - purpose, uses, warnings, do not use, ask a doctor before use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposes
Diphenhydramine Hydrochloride 2%Topical Analgesic
Zinc Acetate 0.1%Skin Protectant

Uses

  • Temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • scrapes
    • minor skin irritations
    • minor cuts
    • rashes due to poison ivy, poison oak and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only

Do Not Use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use

  • on chicken pox
  • on measles

Otc - When Using

When using this product avoid contact with eyes

Stop Use And Ask A Doctor If

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of accidental ingestion, seek medical attention right away or contact a Poison Control Center immediately.

Directions

  • do not use more than directed
  • 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 of age: ask a doctor

Other Information

  • store between 15° and 30° C (59° and 86° F)
  • close cap tightly after use
  • do not use if seal on tube is punctured or missing

Inactive Ingredients

DMDM Hydantoin, GMS, isopropyl myristate, light mineral oil, methylparaben, propylparaben, ritacol, purified water

Questions Or Comments?

1-866-323-0107

Principal Display Panel - 35 G Tube Box

EXTRA STRENGTH

BLOCKS
THE ITCH-CAUSING
HISTAMINES

Natureplex™

Dermamine
Itch Stopping
Cream
Topical Analgesic Skin Protectant

NDC 67234-023-01

NET WT. 1.25 Oz.(35g)

Principal Display Panel (35 g Tube Box)

Principal Display Panel (35 g Tube Box)

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