DCH CALASPRAY ITCH RELIEF- pramoxine hcl 1%, zinc acetate 0.1% spray 
Derma Care Research Labs, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DCH Calaspray Itch Relief Spray, Pramoxine HCl 1%, Zinc Acetate 0.1%

Pramoxine HCl 2%, Zinc Acetate 0.1%


Topical Analgesic, Skin Protectant

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. Dries the oozing and weeping of poison ivy, oak, and sumac.

For external use only. Flammable--Keep away from fire or flame. Do not use on deep or puncture wounds, animal bites, or serious burns. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . 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.

Shake well before use. 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. To apply to face, spray into palm of hand and gently apply.

Alcohol Denat., Camphor, Citric Acid, Ethylhexylglycerin, Fragrance, glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polysorbate 40, Propylene Glycol, Sodium Citrate, Water.

Label

DCH CALASPRAY ITCH RELIEF 
pramoxine hcl 1%, zinc acetate 0.1% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-013-0385 g in 1 CAN; Type 0: Not a Combination Product02/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/18/2021
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-013)

Revised: 6/2023
Document Id: fda2afaf-3ccf-92b3-e053-6394a90a7493
Set id: fda2afaf-3cd0-92b3-e053-6394a90a7493
Version: 1
Effective Time: 20230608
 
Derma Care Research Labs, LLC