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Family Wellness by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Medically reviewed on September 13, 2017

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g, ZINC ACETATE .1g in 100g
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
NDC Code: 55621-007

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

Inactive Ingredients - cetyl alcohol, glycerol stearate,

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

glycol, propylparaben, stearic acid, stearyl alcohol, water

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %

Purpose

---Topical analgesic

---Skin protectant

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor 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 or 4 times per day

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

Other information - store at room temperature 59 - 86 F (15 - 30 C)

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:55621-007
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 MONOSTEARATE 
LAURETH-23 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
STEARIC ACID 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:55621-007-011 TUBE (TUBE) in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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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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