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Diphenhydramine by Physicians Total Care, Inc.

Medically reviewed on Jun 5, 2018

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g, ZINC ACETATE 0.1g in 100g
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-0113

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

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 the 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 than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

1-800-616-2471

Principal Display Panel

Diphenhydramine Hydrochloride 2%

Cream

28 g

NDC 54868-0113-0



Extra Strength

Anti-Itch Cream

Topical Analgesic/Skin Protectant





Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146
DIPHENHYDRAMINE 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0113(NDC:0904-5354)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (ZINC) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PEG-2 STEARATE 
PEG-20 STEARATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:54868-0113-01 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/23/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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