NATURES WILLOW BUG BITE BALM- menthol cream

Natures Willow Bug Bite Balm by

Drug Labeling and Warnings

Natures Willow Bug Bite Balm by is a Otc medication manufactured, distributed, or labeled by WB Ventures LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL Unclassified Section

Drug Facts

Active ingredient

Menthol 1%

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with:

- insect bites

- minor skin irritations

Warnings

For external use only.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

- condition worsens

- symptoms persist for 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.

Keep out of reach of children

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

Directions

Adults and children over 2 years of age: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a physician

Inactive ingredients

Almond Oil, Camphor, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Oil, Geranium Oil, Glyceryl Stearate SE, Helichrysum Gymnocephalum Oil, Isopropyl Palmitate, Jojoba Seed Extract, Lavender Oil, Lemongrass Oil, Palmitic Acid, Phenoxyethanol, Propanediol, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Sunflower Oil, Triethanolamine, Water, White Willow Bark Extract

SPL Unclassified Section

Distributed by WB Ventures LLC, Cincinnati, OH 45212

For more information or to report a serious adverse event contact 1-888-609-4556

Packaging Label

INGREDIENTS AND APPEARANCE

NATURES WILLOW BUG BITE BALM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73498-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPANEDIOL (UNII: 5965N8W85T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
HELICHRYSUM GYMNOCEPHALUM WHOLE (UNII: 0369G6I64W)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
SORBIC ACID (UNII: X045WJ989B)
SALIX ALBA BARK (UNII: 205MXS71H7)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITIC ACID (UNII: 2V16EO95H1)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73498-022-01	1 in 1 CARTON	01/28/2021
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/28/2021

Labeler - WB Ventures LLC (067482664)