GELMICIN HYDROCORTISONE WITH ALOE- hydrocortisone cream

Gelmicin Hydrocortisone with Aloe by

Drug Labeling and Warnings

Gelmicin Hydrocortisone with Aloe by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Hydrocortisone 1%..................................................Anti-itch

PURPOSE

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison ivy, oak sumac
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advise and supervision of a doctor

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.
• more than directed unless directed by a doctor

WHEN USING

When using this product

• avoid contact with eyes
• do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use 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
• rectal bleeding occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• before first use, remove or puncture seal under cap by using the tip of the cap
• for itching of skin irritation, inflammation, and rashes:
• adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor
• for external anal and genital itching, adults:
• when practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

DOSAGE & ADMINISTRATION

Distributed by:

Gute Besserung Hauser

San Diego, CA 92154

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELMICIN HYDROCORTISONE WITH ALOE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WHITE WAX (UNII: 7G1J5DA97F)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-035-40	1 in 1 CARTON	02/22/2021
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/22/2021

Labeler - United Exchange Corp. (840130579)