DERMFREE ANTI-ITCH- hydrocortisone1%, 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 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

When Using

avoid contact with eyes

Stop Use

condition worsens or does not improve within 15 dayssymptoms 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

water 、Glycerol 、Propylene Glycol 、Polydimethylsiloxane 、Trolamine、Borneol 、MENTHA PIPERITA,Methylparaben ,Chlorhexidine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMFREE ANTI-ITCH 
hydrocortisone1%, anti-itch cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-021
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
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHLORHEXIDINE (UNII: R4KO0DY52L)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
BORNEOL (UNII: M89NIB437X)
MENTHA PIPERITA (UNII: 79M2M2UDA9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-021-01	42.5 g in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/15/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-021)