FAMILY WELLNESS MAX STRENGTH 1 HYDROCORTISONE CREAM- hydrocortisone cream 
Family Dollar Stores, Inc

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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Family Wellness Max Strength 1% Hydrocortisone Cream

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

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 fngers 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 of 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 info rmation

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?

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

Package Labeling:

Label3

FAMILY WELLNESS MAX STRENGTH 1 HYDROCORTISONE CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-982
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:55319-982-001 in 1 BOX01/01/2024
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 not finalpart34801/01/2024
Labeler - Family Dollar Stores, Inc (024472631)

Revised: 8/2023
Document Id: 033705bc-f609-4d0c-e063-6394a90aa183
Set id: bca5ac2c-45cd-44e3-98f1-317a04e44d7d
Version: 1
Effective Time: 20230818
 
Family Dollar Stores, Inc