POISON OAK AND IVY- hydrocortisone, phenol gel

POISON OAK AND IVY by

Drug Labeling and Warnings

POISON OAK AND IVY by is a Otc medication manufactured, distributed, or labeled by DeMartini Spring Hill Pharmacy, Inc., Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

HYDROCORTISONE (1%)

PHENOL (0.538%)

PURPOSE

PURPOSE

EXTERNAL ANALGESIC

ASTRINGENT

INDICATIONS & USAGE

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

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

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.

PREGNANCY OR BREAST FEEDING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POISON OAK AND IVY 
hydrocortisone, phenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57479-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1.3 g  in 103 mL
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	0.54 g  in 103 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57479-102-01	103 mL in 1 TUBE; Type 0: Not a Combination Product	08/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/24/2023

Labeler - DeMartini Spring Hill Pharmacy, Inc. (038273603)

Registrant - DeMartini Spring Hill Pharmacy, Inc. (038273603)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(57479-102)