TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH- trolamine salicylate 10% cream

USA - engelska - NLM (National Library of Medicine)

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Produktens egenskaper Produktens egenskaper (SPC)

10-12-2020

Aktiva substanser:
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Tillgänglig från:
Tommie Copper, Inc.
Administreringssätt:
TOPICAL
Receptbelagda typ:
OTC DRUG
Terapeutiska indikationer:
Topical Analgesic. Adults and children 12 years of age : apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily. Children under 12 years of age : ask a doctor.
Bemyndigande status:
OTC monograph not final
Godkännandenummer:
72562-103-03

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TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH- trolamine salicylate 10% cream

Tommie Copper, Inc.

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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Pain Relief Cream, Trolamine Salicylate 10%

Trolamine Salicylate 10%

Topical Analgesic.

For the temporary relief of minor aches and pain associated with simple backache, arthritis, strains,

bruises, and sprains.

For external use only.

Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product use only as directed, avoid taking a bath or shower within 1 hour before or

after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes,

do not apply to wounds or damaged skin.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, if symptoms

clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

Adults and children 12 years of age: apply generously to the affected area, massage into painful area

until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor.

Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula

Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol,

Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia (Coneflower) Extract,

Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract,

Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine,

Water.

TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH

trolamine salicylate 10% cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7256 2-10 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRO LAMINE SALICYLATE (UNII: H8 O40 40 BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)

TROLAMINE SALICYLATE 10 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

JUNIPER BERRY (UNII: O8 4B519 4RL)

CHAMO MILE (UNII: FGL36 8 5T2X)

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

MINERAL O IL (UNII: T5L8 T28 FGP)

PO TASSIUM PHO SPHATE, MO NO BASIC (UNII: 4J9 FJ0 HL51)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7256 2-10 3-0 3

8 5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

12/14/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

12/14/20 20

Labeler -

T ommie Copper, Inc. (081176569)

Tommie Copper, Inc.

Revised: 12/2020

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