DERMACHANGE AID ANTI-ITCH- diphenhydramine hcl gel

Dermachange Aid Anti-Itch by

Drug Labeling and Warnings

Dermachange Aid Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Private Label Beauty and Wellness, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diphenhydramine HCl 2%

PURPOSE

Topical Analgesic.

INDICATIONS & USAGE

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.

WARNINGS

For external use only. Do not use on large areas of the body, with any other products containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 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.

DOSAGE & ADMINISTRATION

Do not use more than directed. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT

Camphor, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Propylene Glycol, SD Alcohol 38-B, Sodium Citrate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMACHANGE AID ANTI-ITCH 
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83520-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
HYPROMELLOSES (UNII: 3NXW29V3WO)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83520-107-03	104 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/31/2024

Labeler - Private Label Beauty and Wellness (035014854)

Registrant - Derma Care Research Labs, LLC (116817470)