FAMILY CARE ANTI-ITCH- hydrocortisone cream 
United Exchange Corp.

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 Care Anti-itch Relief Cream 0.5 oz 494 ZDP

Active ingredient Purpose

Hydrocortisone 1%.......................................................Anti-itch

Uses

Warnings

For external use only

Do not use

Wehn using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

store at room temperature 20-25°C (68-77°F)

Inactive ingredients

aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

494.1

FAMILY CARE ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-494
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-494-141 in 1 CARTON05/10/2022
114 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 finalpart34805/10/2022
Labeler - United Exchange Corp. (840130579)

Revised: 5/2022
Document Id: deb09e89-9795-89a7-e053-2a95a90abdf8
Set id: deb09e89-9794-89a7-e053-2a95a90abdf8
Version: 1
Effective Time: 20220510
 
United Exchange Corp.