ANTI-ITCH WITH ALOE- hydrocortisone 1% cream 
Chain Drug Marketing Association 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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Quality Choice Anti-Itch Cream with Aloe

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to

Warnings

For External Use Only

Do not use for the treatment of diaper rash, consult a doctor.

For external genital itching if you have a vaginal discharge, consult a doctor.

Stop use and ask a doctor

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Other information

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetostearyl alcohol, Edatate Disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, White Petrolatum, Propylene glycol, Purified Water, Sorbitan Monostearate, Polysorbate 60

When using this product

Directions

Adults and children 2 years and older

Children under 2 years of age

For external and anal itching

Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product PRC

Packaging

qc anti itch cream aloe 1oz

ANTI-ITCH WITH ALOE 
hydrocortisone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-688
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
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-688-011 in 1 BOX08/13/2020
128.3 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 finalpart34808/13/2020
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 5/2023
Document Id: fc5f2212-8ecc-e4c8-e053-6394a90a7483
Set id: acc79e55-fa58-2915-e053-2a95a90a0101
Version: 3
Effective Time: 20230523
 
Chain Drug Marketing Association Inc.