REALTREE by Derma Care Research Labs, LLC RealTree Chiggerex

REALTREE by

Drug Labeling and Warnings

REALTREE by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REALTREE- benzocaine 10% ointment 
Derma Care Research Labs, LLC

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RealTree Chiggerex

Benzocaine 10%

Pain Relief

Uses: for the temporary relief of pain and itching associated with chigger bites, red bug bites, ticks, and mosquito bites.

For external use only.

When using this product avoid contact with eyes. Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Water, PEG-2 Stearate, Olea Europaea (Olive) Fruit Extract, Aloe Barbadensis Leaf Extract, Methylparaben, Diazolidinyl Urea, Mentha Piperita (Peppermint) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Propylparaben, Chamomilla Recutita (Matricaria) Flower Extract, PEG-8 Dimethicone, Zea Mays (Corn) Oil, Propylene Glycol, Octyldodecanol, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Pyridoxine HCl, Cholecalciferol, Sodium Propoxyhydroxyproptyl Thiosulfate, Silica, Fragrance, Disodium EDTA, Camphor.

REALTREE 
benzocaine 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-699
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
CLOVE OIL (UNII: 578389D6D0)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
4-DESOXYPYRIDOXINE HYDROCHLORIDE (UNII: P9QAN95HHX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CORN OIL (UNII: 8470G57WFM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
WATER (UNII: 059QF0KO0R)
CHOLECALCIFEROL (UNII: 1C6V77QF41)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-699-01	50 g in 1 JAR; Type 0: Not a Combination Product	08/14/2020	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/14/2020	03/01/2023

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-699)

Revised: 1/2024

Document Id: 0e76cd12-9f38-c98f-e063-6394a90ad9fb

34390-5

Set id: b3ef7b64-3aa4-70b6-e053-2995a90a8de0

Version: 2

Effective Time: 20240108