76986-019 Gembooxt Eczema Relief Cream

76986-019 Gembooxt Eczema Relief Cream
SPL v1
SPL
SPL Set ID 46490d65-f789-eaa2-e063-6294a90a623b
Route
TOPICAL
Published
Effective Date 2025-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Water Ceteareth-25 Dimethicone Dibasic Potassium Phosphate Hydroxyphenyl Propamidobenzoic Acid Butylene Glycol Stearyl Alcohol Xanthan Gum Stearic Acid Camphor (synthetic) Rosa Rugosa Flower Ascorbyl Palmitate Potassium Lauryl Phosphate Triethanolamine Cetyl Alcohol Allantoin Oat Glyceryl Caprylate 1,2-hexanediol Ethylhexyl Palmitate Mineral Oil Menthol Centella Asiatica Triterpenoids Hydroxyacetophenone Pentylene Glycol Glyceryl Stearate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 0.5%) Glycerin Lactobacillus Reuteri F275 Strain Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-19

Description

Hydrocortisone (1%)


Medication Information

Warnings and Precautions

For external use only.

Indications and 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.

Dosage and 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.

Description

Hydrocortisone (1%)

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9

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.

Section 50567-7

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

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

Anti-ltch

Section 55106-9

Hydrocortisone (1%)


Structured Label Content

Indications and Usage (34067-9)



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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-ltch

Section 55106-9 (55106-9)

Hydrocortisone (1%)


Advanced Ingredient Data


Raw Label Data

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