RECOVERY ROLL-ON- menthol, camphor gel

Recovery Roll-On by

Drug Labeling and Warnings

Recovery Roll-On by is a Otc medication manufactured, distributed, or labeled by NATURLAND Magyarorszag Termelo es Kereskedelmi Korlatolt Felelossegu Tarsasag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 5%

Camphor 5%

Purpose

Menthol 5%.............Topical Analgesic

Camphor 5%.............Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

Use only as directed.

For external use only.

When using this product:

• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged skin
• do not bandage tightly or use with a heating pad, other ointments, creams, sprays, or liniments.

Stop use and ask doctor if:

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

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children.If accidentally ingested, get medical help or contact Poison Control Center immediately.

Directions

Adults and children 2 years of age and older:

• Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:

• Consult a doctor.

Other Information

• Store in a cool, dry place.
• Avoid direct sunlight.
• Tamper-evident for your protection. Use only if safety seal is intact.
• Keep away from excessive heat or flame.

Inactive Ingredients

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Dimethyl Sulfone, Magnesium Chloride, Cetearyl Alcohol, Glyceryl Stearate, Polyglyceryl-6 Palmitate/Succinate, Glycerin, Hydroxyacetophenone, Tocopheryl Acetate, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Acacia Senegal Gum, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Magnesium Sulfate, Potassium Chloride, Sodium Chloride, Calcium Chloride

Questions or Comments?

888-819-6472; Monday-Friday, 9am-5pm CT; Report any serious side effects to number above.

PRINCIPAL DISPLAY PANEL

NDC: 72683-008-01

Non-toxic

Paraben Free

Asutra*

Recovery Roll-On

5% Menthol + 5% Camphor

Pain Relief Gel

With Revitalizing Magnesium

1.7 fl. oz. | 50 ml.

INGREDIENTS AND APPEARANCE

RECOVERY ROLL-ON 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84618-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACACIA (UNII: 5C5403N26O)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84618-008-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/17/2022

Labeler - NATURLAND Magyarorszag Termelo es Kereskedelmi Korlatolt Felelossegu Tarsasag (401260559)

Establishment
Name	Address	ID/FEI	Business Operations
NATURLAND Magyarorszag Termelo es Kereskedelmi Korlatolt Felelossegu Tarsasag		401260559	manufacture(84618-008)