Recovery Roll-on (asutra)

Recovery Roll-on (asutra)
SPL v3
SPL
SPL Set ID ebc9630f-6d8b-e4f0-e053-2995a90a0b49
Route
TOPICAL
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (5 g) Menthol
Inactive Ingredients
Polyglyceryl-6 Stearate .alpha.-tocopherol Acetate, D- 1,2-hexanediol Almond Oil Acacia Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Potassium Chloride Sodium Chloride Calcium Chloride Caprylyl Glycol Magnesium Sulfate, Unspecified Form Glycerin Dimethyl Sulfone Cetostearyl Alcohol Water Magnesium Chloride Glyceryl Stearate Se Hydroxyacetophenone Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-17

Description

Menthol 5% Camphor 5%

Purpose

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


Medication Information

Purpose

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

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

Description

Menthol 5% Camphor 5%

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1

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

Section 50566-9

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.
Section 50567-7

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.
Section 51945-4

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.

Section 53414-9

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

Warnings

Use only as directed.

For external use only.

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.
Active Ingredients

Menthol 5%

Camphor 5%

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.


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

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.
Section 51945-4 (51945-4)

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.

Section 53414-9 (53414-9)

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

Purpose

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

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

Warnings

Use only as directed.

For external use only.

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.
Active Ingredients

Menthol 5%

Camphor 5%

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? (Questions or Comments?)

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


Advanced Ingredient Data


Raw Label Data

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