Active Ingredient:

Menthol, USP (1.4%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains associsted 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 breat-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, Chamomilla Recutita (Chamomile) Extract, Chrysanthemum Parthenium (Feverfew) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extarct.

Package Labeling:

Label

SUPER WHITE STUFF PAIN RELIEF
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14448-315
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)
CHAMOMILE (UNII: FGL3685T2X)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
CORIANDER OIL (UNII: 7626GC95E5)
EMU OIL (UNII: 344821WD61)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14448-315-00	5 mL in 1 PACKET; Type 0: Not a Combination Product	04/19/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/19/2021

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