THERA PLUS ANTI-ITCH WITH ALOE HYDROCORTISONE- hydrocortisone cream 
Fourstar Group USA, Inc.

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Thera plus Anti-itch cream with aloe Hydrocortisone cream

Drug Facts

Active ingredients

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only.

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

  • avoid contact with eyes.
  • do not use more than directed unless told to do so by a doctor.
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, cetyl alcohol, disodium EDTA, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Package Labeling:

Label

THERA PLUS ANTI-ITCH WITH ALOE HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80684-038-011 in 1 BOX01/30/2022
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/30/2022
Labeler - Fourstar Group USA, Inc. (140099503)

Revised: 10/2023
Document Id: 08a0f5fb-bc99-45d2-e063-6294a90a623c
Set id: c69d0670-a65b-1680-e053-2995a90a2ee5
Version: 2
Effective Time: 20231026
 
Fourstar Group USA, Inc.