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

Purpose

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

Description

Menthol 5% Camphor 5%


Medication Information

Warnings

Use only as directed.

For external use only.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

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

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

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

Description

Menthol 5% Camphor 5%

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.

Active Ingredients

Menthol 5%

Camphor 5%

Questions Or Comments?

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


Structured Label Content

Warnings

Use only as directed.

For external use only.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

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

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

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

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.

Active Ingredients

Menthol 5%

Camphor 5%

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

All Sections (JSON)