ANTI-ITCH SCALP RELIEF MAXIMUM STRENGTH- hydrocortisone solution 
Delon Laboratories (1990) Ltd

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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Drug Facts

Active Ingredient


Hydrocortisone (1%)

Uses


Temporarily relieves itching associated with minor skin irritation and rashes due to seborrheic dermatitis and psoriasis.

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

Directions

Twist the Flow-Control cap to dispense exactly the amount of product desired:

  • Adults and children 2 years and older: apply to affected areas not more than 3-4 times a day.
  • Children under 2 years of age: do not use, consult a doctor.

Warnings

  • For external use only.
  • When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.
  • Stop use of this product and do not begin use of any other hydrocortisone product if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, unless you have consulted a doctor.
  • Flammable. Keep away from fire or flame.

Purpose

  • External analgesic.

INACTIVE INGREDIENTS

Inactive Ingredients: aloe barbadensis leaf juice, disodium EDTA, melaleuca alternifolia (tea tree) leaf oil, menthol, propylene glycol, alcohol denat., tocopherol acetate, water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Hydrocortisone1 Box

ANTI-ITCH SCALP RELIEF MAXIMUM STRENGTH 
hydrocortisone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61734-415
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
WATER (UNII: 059QF0KO0R) 44.78 g  in 100 g
DISODIUM EDTA-COPPER (UNII: 6V475AX06U) 0.01 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 45 g  in 100 g
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.01 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 5 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 2.7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) 0.25 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 1.1 g  in 100 g
TEA TREE OIL (UNII: VIF565UC2G) 0.05 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.05 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61734-415-0144 g in 1 PACKAGE; Type 0: Not a Combination Product09/09/201412/03/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/09/201412/03/2014
Labeler - Delon Laboratories (1990) Ltd (248364184)
Establishment
NameAddressID/FEIBusiness Operations
Delon Laboratories (1990) Ltd243387722label(61734-415) , manufacture(61734-415) , pack(61734-415)

Revised: 9/2016
 
Delon Laboratories (1990) Ltd