Otc - Active Ingredient
Hydrocortisone (1%)
Gembooxt Eczema Relief Cream
FDA Label NDC 76986-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Gembooxt Eczema Relief Cream (NDC 76986-019). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-ltch
Indications & Usage
Temporarily relieves the itching and discomfort associated with minor skin irritations, rashes, and inflammation, and due to eczema.
Other uses of this product should only be under the advice and supervision of a doctor.
Warnings
For external use only.
Otc - Do Not Use
Do not use if allergic to any ingredients in this product.
Do not use for the treatment of diaper rash.
Do not use more than directed unless told to do so by a doctor.
Otc - When Using
When using this product, avoid contact with eyes, nose and mouth. lf contact occurs, rinse thoroughly with water.
Ask a doctor before use if pregnant or nursing
Otc - Stop Use
Stop using and ask a doctor if condition worsens,symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison control center immediately.
Dosage & Administration
Adults and children 2 years of age and older: apply a thin layer to affected area not more than 3 to 4 times daily.
Children under 2 years of age: ask a doctor.
Inactive Ingredient
WATER
CETYL ALCOHOL
STEARYL ALCOHOL
GLYCERYL STEARATE
GLYCERIN
MINERAL OIL
CETEARETH-25
STEARIC ACID
ETHYLHEXYL PALMITATE
CAMPHOR
MENTHOLUM
CENTELLA ASIATICA EXTRACT
AVENA SATIVA (OAT) KERNEL EXTRACT
ROSA RUGOSA FLOWER EXTRACT
LACTOBACILLUS FERMENT
BUTYLENE GLYCOL
DIMETHICONE
GLYCERYL CAPRYLATE
HYDROXYACETOPHENONE
ETHYLHEXYLGLYCERIN
1,2-HEXANEDIOL
TRIETHANOLAMINE
ALLANTOIN
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
XANTHAN GUM
BUTYLENE GLYCOL
PENTYLENE GLYCOL
HYDROXYPHENYL PROPAMIDOBENZOIC ACID
ASCORBYL PALMITATE
POTASSIUM LAURYL PHOSPHATE
DIPOTASSIUM PHOSPHATE
Package Label.Principal Display Panel
Label1 (Label1)
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