ANTI-ITCH WITH ALOE- hydrocortisone 1% cream

Anti-Itch with Aloe by

Drug Labeling and Warnings

Anti-Itch with Aloe by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc., Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

INDICATIONS & USAGE

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

• insect bites
• eczema
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• external feminine genital and anal itching
• Other uses of this product should be only under the advice and supervision of a doctor.

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

• Conditions worsen
• Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Keep out of the reach of children

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

Other information

• Store at controlled room temperature 20º-25ºC (68º-77ºF)

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

• Avoid contact with the eyes
• do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
• for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
• do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

Adults and children 2 years and older

• apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

• do not use, consult doctor

For external and anal itching

• adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.

• Children under 12 years of age with external anal ithcing consult a doctor.

Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product PRC

Packaging

INGREDIENTS AND APPEARANCE

ANTI-ITCH WITH ALOE 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-688
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-688-01	1 in 1 BOX	08/13/2020
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/13/2020

Labeler - Chain Drug Marketing Association Inc. (011920774)

Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)