Duane Reade
FDA Label NDC 24488-035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Duane Reade for the product Duane Reade (NDC 24488-035). 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 ingredient, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Diphenhydramine hydrochloride 2%........Topical analgesic
Zinc acetate 0.1%.......Skin protectant

Uses

  • temporarily relieves pain and itching 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

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

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

Keep Out Of Reach Of Children.

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

Directions

  • do not use more often 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

  • To open: unscrew cap, use pointed end of cap to puncture seal.
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

purified water aqua/eau; cetyl alcohol; glyceryl stearate; peg-100 stearate; propylene glycol; sodium polyacrylate and ethylhexyl stearate and trideceth-6; methylparaben; propylparaben

Questions

Call 1-866-923-4914

Package Label.Principal Display Panel

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