THERACARE EXTRA STRENGTH ANTI-ITCH CREAM  ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream 
Veridian Healthcare

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.

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TheraCare 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

cetyl alcohol, di sodium edetate, Diazolidinyl urea, methylparaben, peg-100 stearate, peg-2 stearate, petrolatum, potassium hydroxide, polyethylene glycol, propylparaben, stearic acid, water

Questions?

toll-free 866-326-1313

TheraCare Extra Strength Anti-Itch Cream

labelPack

THERACARE EXTRA STRENGTH ANTI-ITCH CREAM   ITCH STOPPING
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-215
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
EDETATE SODIUM (UNII: MP1J8420LU)  
PEG-2 STEARATE (UNII: 94YQ11Y95F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-215-011 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 not finalpart34809/01/2021
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-215)

Revised: 2/2022
Document Id: d8c41944-44a6-11fb-e053-2995a90a11e5
Set id: cb1ab983-4598-d5c0-e053-2a95a90aee09
Version: 2
Effective Time: 20220224
 
Veridian Healthcare