Flexall pain relieving gel

Spl unclassified section

Drug Facts

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only

Allergy alert:

Do not use

if you are allergic to salicylates (including aspirin) unless directed by a doctor.

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

children 12 years or younger: ask a doctor

Inactive ingredients

allantoin, aloe barbadensis leaf juice, carbomer, diisopropyladipate, eucalyptus globulus leaf oil, glycerin, menthapiperita (peppermint) oil, methyl salicylate, SD alcohol 40 (15% w/w), steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water (234-166)

Ingredients and appearance - Product information

Flexall pain relieving gel- Menthol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63187-107
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol, unspecified form ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 0.16 gin 1 g

Inactive Ingredients

Ingredient Name Code
Allantoin ( UNII: 344S277G0Z)
Aloe vera leaf ( UNII: ZY81Z83H0X)
Diisopropyl adipate ( UNII: P7E6YFV72X)
Corymbia citriodora leaf oil ( UNII: M63U6N96EB)
Glycerin ( UNII: PDC6A3C0OX)
Peppermint oil ( UNII: AV092KU4JH)
Methyl salicylate ( UNII: LAV5U5022Y)
Steareth-2 ( UNII: V56DFE46J5)
Steareth-21 ( UNII: 53J3F32P58)
Thyme oil ( UNII: 2UK410MY6B)
.alpha.-tocopherol acetate, d- ( UNII: A7E6112E4N)
Trolamine ( UNII: 9O3K93S3TK)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL( 63187-107), REPACK( 63187-107)

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