VOLTAREN 2% DICLOFENAC LDS GEL

GlaxoSmithKline UK

Revision date : 2020-02-03

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GHS02 GHS07 GHS08
Health risk rating 4
Safety risk rating 2
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

72-<77

EC/CAS

200-578-6/64-17-5

Name of the chemical

Ethanol

Concentration

1-<2

EC/CAS

200-661-7/67-63-0

Name of the chemical

Propan-2-ol

Concentration

1 - < 8

EC/CAS

200-338-0/57-55-6

Name of the chemical

1,2-propanediol

Concentration

3-5

EC/CAS

205-597-3/143-28-2

Name of the chemical

oleyl alcohol

Concentration

N/A

EC/CAS

234-394-2/11138-66-2

Name of the chemical

xanthan gum

Concentration

N/A

EC/CAS

215-185-5/1310-73-2

Name of the chemical

sodium hydroxide

Concentration

4 - < 11

General Information

Revision date

2020-02-03

Product name

VOLTAREN 2% DICLOFENAC LDS GEL

Product Synonyms

DICLOFENAC SODIUM, INVESTIGATIONAL MEDICINAL PRODUCT

1.2.1 Relevant identified uses

Investigational Medicinal Product

Emergency telephone

VERISK 3E GLOBAL INCIDENT RESPONSE

Icons in SDS

GHS02 GHS07 GHS08 T016

Company Information

company name

GlaxoSmithKline UK

e-mail address of the competent person responsible for the Safety Data Sheet

msds@gsk.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H226, H315, H319, H373

Hazard statements

Code

Statements

H226

Flammable liquid and vapour

Section 2

EU Classification

Regulation (EC) No 1272/2008 as amended This mixture does not meet the criteria for classification according to Regulation (EC) 1272/2008 as amended.

Physical hazards

Flammable liquids Category 3 H226 - Flammable liquid and vapour.

Health hazards

Skin corrosion/irritation Category 2 H315 - Causes skin irritation. Serious eye damage/eye irritation Category 2 H319 - Causes serious eye irritation. Specific target organ toxicity - repeated Category 2 H373 - May cause damage to exposure organs through prolonged or repeated exposure. Hazard summary Flammable liquid and vapour. Caution - Pharmaceutical agent. May be harmful if swallowed. Irritating to eyes and skin. May cause an allergic skin reaction. Causes damage to organs through prolonged or repeated exposure. Possible reproductive hazard. See section 11 of the SDS for additional information on health hazards.

2.2 Label elements

Label according to Regulation (EC) No. 1272/2008 as amended

Contains

DICLOFENAC SODIUM, Propylene glycol, SODIUM HYDROXIDE, water, XANTHAN GUM

Signal word

Warning

Hazard statements

H226 Flammable liquid and vapour. H315 Causes skin irritation. H319 Causes serious eye irritation. H373 May cause damage to organs through prolonged or repeated exposure.

Prevention

P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233 Keep container tightly closed. P243 Take action to prevent static discharges. P260 Do not breathe mist/vapours. P264 Wash hands thoroughly after handling. P280 Wear protective gloves/protective clothing/eye protection/face protection.

Response

P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P314 Get medical advice/attention if you feel unwell. P332 + P313 If skin irritation occurs: Get medical advice/attention. P337 + P313 If eye irritation persists: Get medical advice/attention. P362 + P364 Take off contaminated clothing and wash it before reuse. P370 + P378 In case of fire: Use carbon dioxide, foam or dry chemical powder to extinguish.

Storage

P403 + P235 Store in a well-ventilated place. Keep cool.

Disposal

P501 Dispose of contents/container (in accordance with related regulations).

Supplemental label elements

9.17 % of the mixture consists of component(s) of unknown acute oral toxicity. 10.17 % of the mixture consists of component(s) of unknown acute dermal toxicity. 10.17 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 10.17 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment. EUH208 - Contains EUCALYPTUS PERFUME 191134. May produce an allergic reaction.

2.3 Other hazards

Flammable liquid and vapour. Caution - Pharmaceutical agent.

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