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Anti-Itch Cream by Trifecta Pharmaceuticals USA, LLC.

Medically reviewed on Nov 20, 2017

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g, ZINC ACETATE 0.1g in 100g
Labeler: Trifecta Pharmaceuticals USA, LLC.
NDC Code: 69396-025

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.

Anti-Itch Cream

Active Ingredient

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin Protectant

For the temporary relief from pain and itching associated with

  • insect bites
  • minor burns
  • minor skin irritation
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries the weeping and oozing of poison ivy, oak and sumac

Warnings

For External Use Only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use on chicken pox or measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • Conditions worsen or do not improve within 7 days
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

Stop use and ask a doctor
  • Conditions worsen or do 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 the reach of children

If swallowed, get medical help 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: consult a doctor

Other information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)
  • Close cap tightly after use

Questions? Call 1-888-296-9067

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

ANTI-ITCH CREAM 
diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-025
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (ZINC CATION) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LAURETH-23 
WATER 
CETOSTEARYL ALCOHOL 
PETROLATUM 
MINERAL OIL 
STEARYL ALCOHOL 
METHYLPARABEN 
PROPYLENE GLYCOL 
STEARIC ACID 
GLYCERYL MONOSTEARATE 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:69396-025-051 TUBE in 1 BOX
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/29/2016
Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)

 
Trifecta Pharmaceuticals USA, LLC.

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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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