DERMFREE ANTI-ITCH- hydrocortisone acetate1%, anti-itch cream

DERMFREE Anti-itch by

Drug Labeling and Warnings

DERMFREE Anti-itch by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone acetate 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 bymouth

Stop Use

▇condition worsens or does not improve within 15 days

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

Ask Doctor

▇on chicken pox

▇ on measles

Keep Oot Of Reach Of Children

lf swallowed, get medical help or contact aPoison 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、Ethanol 95%、Ethyl paraben、C18-16 Alcohol、 Mono- and di-glycerol fatty acid esters、 Fatty alcohol polyoxyethylene ether、Liquid paraffin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMFREE ANTI-ITCH 
hydrocortisone acetate1%, anti-itch cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LAURETH-9 (UNII: 0AWH8BFG9A)
ETHYLPARABEN (UNII: 14255EXE39)
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-102-01	42.5 g in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/22/2025

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-102)