Medication Guide App

PREMIER VALUE ALLERGY

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g, ZINC ACETATE 0.1g in 100g
Labeler: TAI GUK PHARM. CO., LTD.
NDC Code: 68169-0127

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.

Drug Facts

Active Ingredients                                                                            Purpose

Diphenhydramine Hydrochloride USP, 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 area of the body or with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use

on chicken pox or 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.

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
  • discontinue use and consult a physician if rash or irritation develops

Other information

  • store at 20o to 25oC (68o to 77oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd., Suite 101

Boca Raton, FL 33431

Inactive ingredients

glycerin, sodium chloride, petrolatum, cetyl alcoho, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water, hydroxyethyl cellulose

Enter section text here

PREMIER VALUE ALLERGY  
diphenhydramine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0127
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
GLYCERIN 
SODIUM CHLORIDE 
PETROLATUM 
CETYL ALCOHOL 
DIMETHICONE 
ISOPROPYL PALMITATE 
DISTEARYLDIMONIUM CHLORIDE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:68169-0127-61 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 finalpart34809/17/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIOperations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 09/2010
 
TAI GUK PHARM. CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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