ASTONEA EXTRA STRENGTH ANTI-ITCH CREAM ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA Extra Strength Anti-Itch Cream

Drug Facts

Active ingredientsPurpose
Diphenhydramine hydrochloride 2%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product

  • use only as directed
  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • 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. (1-800-222-1222)

Directions

Other information

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Edetate disodium, Light Mineral Oil, Petrolatum, Propylene Glycol, Sodium metabisulsulfite, Water

ASTONEA Extra Strength Anti-Itch Cream

Principal Display and Drug Fact Panel

ASTONEA EXTRA STRENGTH ANTI-ITCH CREAM  ITCH STOPPING
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CHLOROCRESOL (UNII: 36W53O7109)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
CETETH-20 (UNII: I835H2IHHX)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-215-011 in 1 CARTON09/01/2021
135.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/01/2021
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 12/2023
Document Id: 0d81a85f-708a-156c-e063-6294a90aefff
Set id: 0d81b0dc-c86a-21bc-e063-6294a90a420a
Version: 1
Effective Time: 20231227
 
ASTONEA LABS PRIVATE LIMITED