DERMACHANGE AID ANTI-ITCH- diphenhydramine hcl gel 
Private Label Beauty and Wellness

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Dermachange Aid Anti-Itch Gel, Diphenhydramine HCl 2%

Diphenhydramine HCl 2%


Topical Analgesic.

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.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

Label

DERMACHANGE AID ANTI-ITCH 
diphenhydramine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83520-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83520-107-03104 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/31/2024
Labeler - Private Label Beauty and Wellness (035014854)
Registrant - Derma Care Research Labs, LLC (116817470)

Revised: 3/2024
Document Id: 12ed906c-d027-0ff7-e063-6394a90aaa52
Set id: 12ed906c-d028-0ff7-e063-6394a90aaa52
Version: 1
Effective Time: 20240305
 
Private Label Beauty and Wellness