SUPER BLUE STUFF PAIN RELIEF CREAM- menthol cream 
Blue Spring International, LLC

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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SUPER BLUE STUFF Pain Relief Cream

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:14448-314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14448-314-0385 mL in 1 CYLINDER; Type 0: Not a Combination Product11/22/2020
2NDC:14448-314-04118 mL in 1 JAR; Type 0: Not a Combination Product11/22/2020
3NDC:14448-314-12355 mL in 1 CYLINDER; Type 0: Not a Combination Product11/22/2020
4NDC:14448-314-175 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/22/2020
Labeler - Blue Spring International, LLC (182950118)

Revised: 5/2021
Document Id: c3247719-c98f-92c8-e053-2a95a90ad637
Set id: 066a2106-2e25-4df6-9a8d-4417ba190205
Version: 2
Effective Time: 20210525
 
Blue Spring International, LLC