RAEL PAIN RELIEF ROLL-ON ANALGESIC (camphor- synthetic and menthol, unspecified form liquid

Rael PAIN RELIEF ROLL-ON by

Drug Labeling and Warnings

Rael PAIN RELIEF ROLL-ON by is a Otc medication manufactured, distributed, or labeled by Rael, Inc., Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 4%	Topical analgesic
Menthol 4%	Topical analgesic

Uses

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

Warnings

For external use only

When using this product

• avoid contact with the eyes
• use only as directed
• do not apply to wounds or damaged skin
• do not bandage tightly.

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

Other information

• store in a cool dry place with the lid closed tightly.

Inactive ingredients

Alcohol Denat, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arnica Montana Extract, Caffeine, Calendula Officinalis Flower Extract, Carbomer, Curcuma Longa (Turmeric) Root Extract, Cymbopogon Flexuosus Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Glyceryl Stearate Se, Hydrolyzed Hyaluronic Acid, Isohexadecane, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Methyl Glucose Sesquistearate, Phenoxyethanol, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Water, Zingiber Officinale (Ginger) Root Extract, Zingiber Officinale (Ginger) Root Oil

Questions?

For questions and general information visit us at www.getrael.com/pages/contact

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

Rael

PAIN
RELIEF

ROLL-ON
FOR CRAMPS

R

Temporarily relieves
PMS aches and pains

FAST-ACTING

1.7 fl. oz. | 50ml

MASSAGING ROLLERBALL

*Not actual
size

4% Camphor
4% Menthol
Magnesium

INGREDIENTS AND APPEARANCE

RAEL PAIN RELIEF ROLL-ON  ANALGESIC
camphor (synthetic) and menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72863-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
Caffeine (UNII: 3G6A5W338E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TURMERIC (UNII: 856YO1Z64F)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexylglycerin (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CLOVE LEAF OIL (UNII: VCA5491KVF)
METHYL SALICYLATE (UNII: LAV5U5022Y)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
HYALURONIC ACID (NON-ANIMAL STABILIZED) (UNII: B7SG5YV2SI)
Isohexadecane (UNII: 918X1OUF1E)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PEPPERMINT OIL (UNII: AV092KU4JH)
Methyl Glucose Sesquistearate (UNII: V1YW10H14D)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylene Glycol (UNII: 6DC9Q167V3)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
Water (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)
GINGER OIL (UNII: SAS9Z1SVUK)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72863-076-01	1 in 1 CARTON	10/09/2024
1		50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	10/09/2024

Labeler - Rael, Inc. (087378348)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(72863-076) , LABEL(72863-076) , PACK(72863-076)