Recovery Roll-on
FDA Label NDC 75249-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Soliteint Kozmetikum Gyarto Es Forgalmazo Termelo Es Kereskedelmi Korlatolt Felelossegu Tarsasag for the product Recovery Roll-on (NDC 75249-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

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.

Otc - When Using

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.

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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