POISON OAK AND IVY- hydrocortisone, phenol gel 
DeMartini Spring Hill Pharmacy, 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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HYDROCORTISONE (1%)

PHENOL (0.538%)

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: SD Alcohol 40-B, Aqua, Witch Hazel Distillate, Alcohol (Ethanol-Natural Grain USP), Acrylates/C10-30, Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, *CO Aloe Vera Leaf Powder, Citrus Limon (Lemon) Peel Oil, Benzyl Alcohol, Blue 1 *CO certified organic

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.

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POISON OAK AND IVY 
hydrocortisone, phenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57479-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.3 g  in 103 mL
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.54 g  in 103 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LEMON JUICE (UNII: AGN709ANTJ)  
WITCH HAZEL (UNII: 101I4J0U34)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57479-102-01103 mL in 1 TUBE; Type 0: Not a Combination Product08/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/24/2023
Labeler - DeMartini Spring Hill Pharmacy, Inc. (038273603)
Registrant - DeMartini Spring Hill Pharmacy, Inc. (038273603)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(57479-102)

Revised: 8/2023
Document Id: 03aeed00-2028-0b57-e063-6394a90a8b47
Set id: 03aeed00-2027-0b57-e063-6394a90a8b47
Version: 1
Effective Time: 20230824
 
DeMartini Spring Hill Pharmacy, Inc.