ALOE CORT- hydrocortisone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)
Available from:
Topiderm, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antipruritic cream For the temporary relief of itching from minor skin irritations, and rashes - Other uses of this product should be only under the supervision of a doctor.
Authorization status:
OTC monograph not final
Authorization number:
51326-108-57

ALOE CORT- hydrocortisone cream

Topiderm, 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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Aloe Cort Cream

Drug Facts

Active ingredient

Hydrocortisone USP 1%

Purpos e

Antipruritic cream

Us es

For the temporary relief of itching from minor skin irritations, and rashes

Other uses of this product should be only under the supervision of a doctor.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily, or

as directed. Consult a physician for children under 2 years of age.

Warnings

For external use only

Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days, or

clear up and occur again within a few days, stop use of this product and consult a physician

Do not use for treatment of diaper rash

Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison

Control Center immediately.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Dimethicone,

Glycerin, Imidazolidinyl Urea, Methylparaben, PPG-2 Myristyl Ether Propionate, Polysorbate-60,

Propylparaben, Purified Water, Squalane, Triethanolamine.

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

DERMA

TOPIX

aloe cort cream

Hydrocortisone USP, 1%

Net wt. 2 oz. (57g)

Topix Pharmaceuticals, Inc. N. Amityville, NY 11701

DERMA

TOPIX

ALOE CORT

hydrocortisone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51326 -10 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Hydro co rtiso ne (UNII: WI4X0 X7BPJ) (Hydro co rtiso ne - UNII:WI4X0 X7BPJ)

Hydro c o rtiso ne

0 .57 g in 57 g

Inactive Ingredients

Ingredient Name

Stre ng th

Alo e (UNII: V5VD430 YW9 )

Yello w Wa x (UNII: 2ZA36 H0 S2V)

Benzyl Alco ho l (UNII: LKG8 49 4WBH)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

Topiderm, Inc.

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

Glycerin (UNII: PDC6 A3C0 OX)

Imidurea (UNII: M6 29 8 0 7ATL)

Methylpa ra ben (UNII: A2I8 C7HI9 T)

PPG-2 Myristyl Ether Pro pio na te (UNII: 8 8 R9 7D8 U8 A)

Po lyso rba te 6 0 (UNII: CAL22UVI4M)

Pro pylpa ra ben (UNII: Z8 IX2SC1OH)

Wa ter (UNII: 0 59 QF0 KO0 R)

Squa la ne (UNII: GW8 9 575KF9 )

Tro la mine (UNII: 9 O3K9 3S3TK)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51326 -10 8 -57

57 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 2/27/19 9 0

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 2/27/19 9 0

Labeler -

T opiderm, Inc. (049121643)

Revised: 9/2019

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