ATOMIC BALM- methyl salicylate, capsaicin ointment 
Performance Health, LLC

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.

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Atomic Balm Ointment

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:

Label4

ATOMIC BALM 
methyl salicylate, capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-999
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12.5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-999-2178 g in 1 TUBE; Type 0: Not a Combination Product05/19/201712/31/2024
2NDC:59316-999-96454 g in 1 JAR; Type 0: Not a Combination Product05/19/201712/31/2024
3NDC:59316-999-972268 g in 1 JAR; Type 0: Not a Combination Product05/19/201712/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/201712/31/2024
Labeler - Performance Health, LLC (794324061)

Revised: 8/2022
Document Id: e5b3882e-1ef8-923a-e053-2a95a90ab807
Set id: 74b5e39d-4af8-4397-b2b4-e311b209e06e
Version: 7
Effective Time: 20220807
 
Performance Health, LLC