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POISON OAK

Medically reviewed on March 19, 2018

Dosage form: gel
Ingredients: HYDROCORTISONE 1g in 100g, PHENOL 0.5g in 100g
Labeler: DeMartini Spring Hill Pharmacy, Inc.
NDC Code: 57479-101

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.

HYDROCORTISONE (1% W/W)

PHENOL (0.5%)

PURPOSE

EXTERNAL ANALGESIC

ASTRINGENT

USES: POISON OAK, POISON SUMAC, POISON IVY, MOSQUITO BITES, OTHER ALLERGIC RASHES.

WARNINGS: FOR EXTERNAL USE ONLY. DO NOT USE ON EEP OR PUNCTURE WOUNDS, ANIMAL BITES, OR SERIOUS BURNS.

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP ORCONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS FOR USE: APPLY DIRECTLY TO THE RASH AREA 3 TO 5 TIMES DAILY OR AS NEEDED FOR THE RELIEF OF ITCHING, REDNESS OR WEEPING.

INACTIVE INGREDIENTS:  Alcohol Denat, Acrylates/C10-30, Alkyl Acrylate Crosspolymer, Aloe Vera Gel, Benzyl Alcohol, Blue 6, Citrus Medica Limonum (Lemon) Juice Extract, Hamamelis Virginiana, Potassium Hydroxide, Water

When using this product
• Avoid getting in eyes or mucus membranes. If contact occurs rinse thoroughly with water.
• Discontinue use if allergic to any of the components.

Stop use and ask a doctor if
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

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

POISON OAK 
hydrocortisone, phenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57479-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
PHENOL (PHENOL) PHENOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
ALOE VERA LEAF 
BENZYL ALCOHOL 
D&C BLUE NO. 6 
LEMON JUICE 
WITCH HAZEL 
POTASSIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:57479-101-13100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/29/2012
Labeler - DeMartini Spring Hill Pharmacy, Inc. (038273603)
Registrant - DeMartini Spring Hill Pharmacy, Inc. (038273603)

 
DeMartini Spring Hill Pharmacy, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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