Inactive Ingredient
Inactive Ingredients - cetyl alcohol, glycerol stearate,
laureth-23, methylparaben, mineral oil, petrolatum, propylene
glycol, propylparaben, stearic acid, stearyl alcohol, water
Family Wellness Cream
FDA Label NDC 55621-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Family Wellness (NDC 55621-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Diphenhydramine hydrochloride 2 %
Zinc acetate 0.1 %
Otc - Purpose
Purpose
---Topical analgesic
---Skin protectant
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use
-over large areas of the body
-with any other product containing diphenhydramine,
including those taken orally
Otc - When Using
When using this product - avoid contact with eyes
Otc - Ask Doctor
Ask a doctor before use
-on chicken pox
-on measles
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.
Dosage & Administration
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
Storage And Handling
Other information - store at room temperature 59 - 86 F (15 - 30 C)
Otc - Questions
Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST
Package Label.Principal Display Panel
Copy Of Label (Zhejiang Antilabel)
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