OTC Medication Information: Analgesic Balm

ANALGESIC BALM- menthol and methyl salicylate cream
Geri-Care Pharmaceuticals, Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient

Menthol 10%

Active Ingredient

Methyl Salicylate 15%

Topical Analgesic

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

Warnings

For external use only

Do not use:

  • On wounds or damaged, broken (open) or irritated skin
  • On a child under 12 years of age with arthritis-like conditions
  • With a heating pad

Ask a doctor before use if you have redness over the affected area.

When using this product

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop Use and ask a doctor

  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

Keep out of the reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Use only as directed
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Other Information

  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-800-540-3765

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Distributed By

Distributed By

GeriCare Pharmaceuticals

1650 63rd Street

Brooklyn, NY 11204

Made in China

Packaging

Gericare Muscle rub cream 3oz
(click image for full-size original)

ANALGESIC BALM
menthol 10%, methyl salicylate 15% cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
TROLAMINE
CARBOMER 940
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
METHYLPARABEN
WATER
STEARIC ACID
GLYCERIN
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-116-03 1 TUBE in 1 BOX contains a TUBE
1 85 g in 1 TUBE This package is contained within the BOX (57896-116-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/30/2021
Labeler — Geri-Care Pharmaceuticals, Corp (611196254)
Registrant — Trifecta Pharmaceuticals USA LLC. (079424163)

Revised: 07/2021 Geri-Care Pharmaceuticals, Corp

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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