ATOMIC BALM- methyl salicylate, capsaicin ointment

Atomic Balm by

Drug Labeling and Warnings

Atomic Balm by is a Otc medication manufactured, distributed, or labeled by Performance Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Methyl Salicylate 12.5%

Capsaicin 0.025%

Purpose

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, and arthritis. Combined with stretching and calisthenics,  Atomic Balm assists in the warm-up process, especially in cool, damp weather. Do not bandage tightly.

Warnings

For external use only.
Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. Consult a doctor before administering to children, including teenagers, with chicken pox or flu.

Keep this and all drugs out of the reach of children

to avoid accidental poisoning.

Directions

Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply: spread 1/8 " layer of Atomic Balm over area. Do not bandage tightly.

Other information

This product will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Use with caution on sensitive skin. Store in a cool, dry place with cap closed tightly.

Inactive Ingredients

Lanolin, Paraffin, Petrolatum

Questions?

(800) 345-2231

Package Labeling:

INGREDIENTS AND APPEARANCE

ATOMIC BALM 
methyl salicylate, capsaicin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	12.5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-999-21	78 g in 1 TUBE; Type 0: Not a Combination Product	05/19/2017
2	NDC: 59316-999-96	454 g in 1 JAR; Type 0: Not a Combination Product	05/19/2017
3	NDC: 59316-999-97	2268 g in 1 JAR; Type 0: Not a Combination Product	05/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/19/2017

Labeler - Performance Health, LLC (794324061)