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Family Wellness by FRONT PHARMACEUTICAL PLC

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g, ZINC ACETATE .1g in 100g
Labeler: FRONT PHARMACEUTICAL PLC
NDC Code: 69571-005

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 Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses for temprary relief from pain and itching associated

with insect bites , sunburn and mior skin irritations. Dries the

oozing and weeping of poison: •ivy  •oak  •sumac

Warnings

For external use only.

Do not use

  • over large areas of the body
  • with any other product containing diphenhydramine including those taken orally

When using this product •avoid contact with eyes

Ask a doctor before use

•on chicken pox  •on measles

Stop use and ask a doctor if

  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and then 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

•for adults and children over 2 years of age: apply to affected

area not more than 3 to 4 times daily

•children under 2 years of age: ask a doctor before use

Other information store at room temperature 59° - 86° F

(15° - 30° C).

Inactive ingredients cetyl alcohol, glyceryl stearate se,

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearic alcohol, water

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

FAMILY WELLNESS 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-005
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 CATION.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
GLYCERYL STEARATE SE 
LAURETH-23 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
STEARIC ACID 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:69571-005-021 TUBE in 1 BOX
1NDC:69571-005-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/29/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIOperations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-005)

Revised: 03/2017
 
FRONT PHARMACEUTICAL PLC

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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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