WILLOW BALM- topical pain reliever cream 
I Woke Up Well Distributing 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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Willow Balm Nature's Aspirin

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

Main Label

WILLOW BALM 
topical pain reliever cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71629-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71629-035-011 g in 1 TUBE; Type 0: Not a Combination Product01/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/15/2018
Labeler - I Woke Up Well Distributing Inc (025251119)
Registrant - I Woke Up Well Distributing Inc (025251119)

Revised: 1/2018
Document Id: 62d35ec4-83f1-a19a-e053-2a91aa0a863f
Set id: 62d35ec4-83f0-a19a-e053-2a91aa0a863f
Version: 1
Effective Time: 20180115
 
I Woke Up Well Distributing Inc