DERMFREE ANTI-ITCH CREAM- hydrocortisone1% anti-itch cream cream

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Use

temporarily relieves pain and itching associated with:▇insect bites▇ minor burns ▇sunburn▇ minor skin irritations▇ minor cuts ▇scrapes▇ rashes due to poison ivy, poison oak, and poison sumac ▇dries the oozing and weeping of poison ivy, poison oak ，and poison sumac

Warnings

For external use only.

Do not use

▇on large areas of the body

▇with any other product containing diphenhydramine, even one taken by mouth

When Using

avoid contact with eyes

Stop Use

▇condition worsens or does not improve within 15 days

▇symptoms persist for more than 15 days or clear up and occur again within a few days

Ask Doctor

▇condition worsens or does not improve within 15 days

▇symptoms persist for more than 15 days or clear up and 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

▇do not use more than directed

▇adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ▇children under 2 years of age: ask a doctor

Other information

▇protect from excessive heat (40°C/104°F)

Inactive ingredients

Purified Water, Polysorbate 80, Phenoxyethanol, C18‑16 Alcohol, Glyceryl Stearate, Stearic Acid, Liquid Paraffin, 95%(v/v) Ethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMFREE ANTI-ITCH CREAM 
hydrocortisone1% anti-itch cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87686-001
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
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87686-001-01	42.5 g in 1 TUBE; Type 0: Not a Combination Product	05/12/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/12/2026

Labeler - Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. (411295811)