Active Ingredient:

Menthol, USP (1.4%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains associated with arthritis, simple backache, sprains, strains and bruises.

Warnings:

For external use only.

Do not use

on wounded, damaged or irritated skin.

When using this product

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop use and ask a doctor if

you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clears up and occurs again within a few days.

If Pregnant or Breast-Feeding

ask a health professional before use.

Consult a doctor

before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply to affected area not more than 3 or 4 time a day.

Other Information:

Store at room temperature.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf(Aloe Vera Gel)Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Sali Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden)Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extract, FD&C Blue #1

Questions or Comments?

1-800-452-3700 or www.bluespringwellness.com

Package Labeling:85ml

Bottle

Package Labeling:118ml

Bottle2

Package Labeling:355ml

Bottle3

Package Labeling: 5ml

Pack

SUPER BLUE STUFF PAIN RELIEF CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14448-314
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CORIANDER OIL (UNII: 7626GC95E5)
EMU OIL (UNII: 344821WD61)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
EDETATE SODIUM (UNII: MP1J8420LU)
TILIA CORDATA WHOLE (UNII: W5E5UB44GD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14448-314-03	85 mL in 1 CYLINDER; Type 0: Not a Combination Product	11/22/2020
2	NDC:14448-314-04	118 mL in 1 JAR; Type 0: Not a Combination Product	11/22/2020
3	NDC:14448-314-12	355 mL in 1 CYLINDER; Type 0: Not a Combination Product	11/22/2020
4	NDC:14448-314-17	5 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/22/2020

Labeler - BLUE SPRING WELLNESS, L.L.C. (182950118)

SUPER BLUE STUFF Pain Relief Cream