HEALTHY BACK INSTITUTE RUB ON RELIEF- analgesic cream

Healthy Back Institute Rub On Relief by

Drug Labeling and Warnings

Healthy Back Institute Rub On Relief by is a Otc medication manufactured, distributed, or labeled by Eagle Labs Inc., Eagle Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Camphor 3%

Purpose

Topical Analgesic

Uses:

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

WARNINGS:

For external use only ▪Avoid contact with the eyes ▪ Do not apply to wounds or bandaged skin ▪ Do not bandage

Stop use and consult a doctor if: ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and reoccur ▪redness is present ▪irritation develops

Keep out of reach of children

Keep out of the reach of children.
If accidentally swallowed get medical help or contact a Poison Control Center immediately.

If pregnant or breast-feeding:

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Stop Usage immediately and as a doctor if:

The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops

WHEN USING THIS PRODUCT

When using this product ▪ use only as directed ▪ do not apply heat (heating pads) or apply patches to area ▪ do not use with other topical analgesics - avoid contact with eyes, mucos membranes, and genital area - Do not expose application site to heat or direct sunlight

Other Information

Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

Directions:

Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.

Inactive Ingredients:

Aloe Barbadensis Inner Leaf Juice, Aqua, Arnica Montana Flower Extract, Ricinus Communis (Castor) Seed Oil, Cetyl Myristoleate, Glycerin USP, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Methyl Sulfonyl Methane, Palmitoylethanolamide, Butyrospermum Parkii (Shea) Butter, D-Alpha Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Salix Alba (Willow) Bark Extract.

RUB THE PAIN AWAY

Rub On Relief Net Wt 3.0 OZ (88mL)

INGREDIENTS AND APPEARANCE

HEALTHY BACK INSTITUTE RUB ON RELIEF 
analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79804-618
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL RICINOLEATE (UNII: ZUE0CEL42O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
LAVENDER OIL (UNII: ZBP1YXW0H8)
DEMETON-S-METHYLSULFONE (UNII: RSO143122K)
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)) (UNII: F72017VPR7)
SHEA BUTTER (UNII: K49155WL9Y)
WILLOW BARK (UNII: S883J9JDYX)
DISODIUM .ALPHA.-TOCOPHERYL PHOSPHATE, D- (UNII: 7D2U5UV9RA)
TURMERIC (UNII: 856YO1Z64F)

Product Characteristics
Color	white (White to off white - opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79804-618-03	87.1 g in 1 PACKAGE; Type 0: Not a Combination Product	06/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/03/2024

Labeler - Eagle Labs Inc. (118496872)

Registrant - Eagle Labs Inc (118496872)