WILLOW BALM- topical pain reliever cream

Willow Balm by

Drug Labeling and Warnings

Willow Balm by is a Otc medication manufactured, distributed, or labeled by I Woke Up Well Distributing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 3% Counterirritant

Warnings

WARNINGS for external use only. Use only as directed. Avoid contact
with eyes and mucus membranes. Do not cover with bandage. Do not use on open wounds or damaged skin.
Keep out of reach of Children. Consult physician for children under 12.

Uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

Other Ingredients

BOTANICALS White Willow Bark, Camphor, Eucalyptus Oil, Lavender Oil, Geranium Oil, Helichrysum Gymnocephalum Oil,
Spearment Oil OTHER INGREDIENTS water, mineral oil, cetyp alcohol, stearic acid, stearyl alcohol, cetearyl alcohol,
cetereth, propylene glycol, isopropyl palmtate, almond oil, glycol monostearate, phenoxy ethanol, caprylyl glycol,
jojoba seed oil

Contact information

For more informatin contact us at: 888-609-4556, or visit www.willowbalm.com Made in the USA I Woke Up Well Distributing, Inc. US Pat. 8765194

Warnings

Keep Out Of Reach of Children

Directions

Apply the product directly to the affected area. Product may be used as necessary, but should not be used more than four times daily.

Purpose

Use for the temporary relief of minor aches and muscle pains.

main label

INGREDIENTS AND APPEARANCE

WILLOW BALM 
topical pain reliever cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71629-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)	0.013 g  in 1 g
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.013 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.095 g  in 1 g
WATER (UNII: 059QF0KO0R)	0.072 g  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	0.0238 g  in 1 g
HELICHRYSUM GYMNOCEPHALUM WHOLE (UNII: 0369G6I64W)	0.009 g  in 1 g
STEARIC ACID (UNII: 4ELV7Z65AP)	0.238 g  in 1 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	0.119 g  in 1 g
ALMOND OIL (UNII: 66YXD4DKO9)	0.019 g  in 1 g
TROLAMINE (UNII: 9O3K93S3TK)	0.013 g  in 1 g
CETEARETH-10 (UNII: K9YLE2L8PA)	0.476 g  in 1 g
SALIX ALBA BARK (UNII: 205MXS71H7)	0.049 g  in 1 g
SPEARMINT (UNII: J7I2T6IV1N)	0.002 g  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662)	0.078 g  in 1 g
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)	0.0095 g  in 1 g
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)	0.078 g  in 1 g
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)	0.019 g  in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	0.571 g  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71629-035-01	1 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/15/2018

Labeler - I Woke Up Well Distributing Inc (025251119)

Registrant - I Woke Up Well Distributing Inc (025251119)