AVON HEXASHIELD PAIN RELIEF FOR MUSCLE, BACK AND JOINT CREAM- camphor, menthol, methyl salicylate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)
Available from:
Tai Guk Pharm. Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic Temporary relieves the minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains
Authorization status:
OTC monograph not final
Authorization number:
43136-102-01

AVON HEXASHIELD PAIN RELIEF FOR MUSCLE, BACK AND JOINT CREAM- camphor,

menthol, methyl salicylate cream

Tai Guk Pharm. Co., Ltd.

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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AVON HeXashield Pain Relief Cream for Muscle, Back And Joint

Active Ingredient

Camphor 4 %

Menthol 10 %

Methyl salicylate 30 %

Purpos e

Topical analgesic

Us es

Temporary relieves the minor aches and pains of muscles and joints associated with:

simple backache

arthritis

strains

bruises

sprains

Warnings

For external use only.

Do not use

on wounds or damaged skin

with a heating pad

on a child under 12 years of age with arthritis-like conditions

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 banage tightly

Stop use and ask a doctor if :

condition worsens or symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive skin irritation occurs

Keep out of reach of children.

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

Directions

use only as directed

adults and children 12 years of age and older : apply to affected area not more than 3 to 4 times

daily

children under 12 years of age : ask a doctor

Other information

store at room temperature

Inactive Ingredients

glycerin, isopropyl myristate, lanolin, methylparaben, petrolatum, polysorbate 60, potassium cetyl

phosphate, propylparaben, sorbitan monostearate, stearyl alcohol water

Questions or comments?

Call toll free 1-800-FOR-AVON

www.avon.com

Principal Display Panel

HeXasheild

PAIN RELIEF CREAM

FOR MUSCLE,

BACK AND JOINT

Camphor, Menthol, Methyl salicylate

Fast relief of muscle, back and joint pain

Deep Penetrating, Fast Acting Relief

ULTRA STRENGTH

AVON

NET WT 2 oz (56.7 g)

AVON HEXASHIELD PAIN RELIEF FOR MUSCLE, BACK AND JOINT CREAM

camphor, menthol, methyl salicylate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43136 -10 2

Tai Guk Pharm. Co., Ltd.

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LEVO MENTHO L (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)

LEVOMENTHOL

10 0 mg in 1 g

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

30 0 mg

in 1 g

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

WATER (UNII: 0 59 QF0 KO0 R)

PETRO LATUM (UNII: 4T6 H12BN9 U)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

GLYCERIN (UNII: PDC6 A3C0 OX)

LANO LIN (UNII: 7EV6 5EAW6 H)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:43136 -10 2-0 1

1 in 1 CARTON

0 7/31/20 19

1

56 .7 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

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

0 7/31/20 19

Labeler -

T ai Guk Pharm. Co., Ltd. (689060246)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tai Guk Pharma. Co ., Ltd.

6 8 9 0 6 0 246

ma nufa c ture (43136 -10 2)

Revised: 7/2019

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