Diphenhydramine Hydrochloride And Zinc Acetate Cream
FDA Label NDC 70677-1213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Diphenhydramine Hydrochloride And Zinc Acetate (NDC 70677-1213). 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, uses, warnings, do not use, ask a doctor before use, otc - when using, stop use and ask a doctor if, otc - 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

Other

Drug Facts

Distributed by:McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

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

Otc - When Using

When using this productavoid 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 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 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water

Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel - 28.4 G Tube Carton

Foster & Thrive™

EXTRA STRENGTH

Anti-Itch Cream

Diphenhydramine Hydrochloride 2% and Zinc Acetate 0.1%

TOPICAL ANALGESIC / SKIN PROTECTANT

NET WT 1 OZ (28.4 g)

Principal Display Panel (28.4 g Tube Carton)

Principal Display Panel (28.4 g Tube Carton)

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