Diphenhydramine
FDA Label NDC 40002-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nexmed (usa), Inc. for the product Diphenhydramine (NDC 40002-004). 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, ask a doctor before use, when using this product, stop use and ask a doctor if, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical Analgesic

Skin protectant

Uses

  • For the temporary relief of itching and pain associated with:
  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • 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.

Ask A Doctor Before Use

  • on chicken pox
  • on measles

When Using This Product

  • avoid contact with the eyes

Stop Use And Ask A Doctor If

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


Do Not Use

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

Keep Out Of Reach Of Children.

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

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, or as directed by a doctor
  • children under 2 years of age, consult a doctor

Other Information

  • Store between 20o and 25oC (68o to 77oF)
  • Lot no. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Otc - Questions

Call 1-866-580-7391, Mon - Fri, 8:30 AM - 5:30 PM (PST)

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